Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

No use of the decision aid dashboard before, during or after the treatment decision time period.

Use of the decision aid dashboard before, during and after the treatment decision time period.

With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.

Dashboard

James G Dolan

The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.

The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.

Specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on:

1. patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer,
2. measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process,
3. the treatments selected, and
4. 3-6 and 9-12 month outcome assessments of clinical status, decision regret, cancer-related quality of life including worry, functional status, and treatment side effects.

Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer

CDC SIP: Rochester Prevention Research Center: Development and Evaluation of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer

The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.

The use of the dashboard will improve the overall quality and satisfaction with initial treatment decisions as measured by a) decisional conflict, b) patient quality of life, and c) post-decision regret, using the PORPUS questionnaire and Decisional Regret questionnaire.

University of Rochester

Associate Professor

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The control arm will receive counseling regarding treatment options using standard patient-physician interactions and nomogram-predicted probabilities of treatment outcome for the various treatment options and they will be unaware of the decision analysis recommendation.

The treatment arm would be provided with a personalized treatment recommendations based on the decision analysis model prior to treatment selection.

This is a psychosocial/behavioral study. It will use a randomized trial to test the hypothesis that a decision analysis model that provides individualized estimates of quality-adjusted disease-free survival for each of the treatment options for clinically localized prostate cancer will lead to higher quality treatment decisions congruent with a patient's values leading to improved decisional regret and treatment satisfaction. In this trial, all patients would be evaluated at baseline for their utilities for various clinically important health states. The primary endpoint of this study will be regret-free survival at 2 years after treatment. There will be a 1:1 randomization. A random permuted design will be used to assure approximate balanced number of patients in the two groups over time.

Personalized Treatment Recommendations

Both patients and physicians will be unaware of the decision analysis recommendation and the patients will receive standard treatment counseling alone. After the patient has made a treatment decision he will be given a short questionnaire to assess decisional conflict. If after one month no treatment decision information is available, a letter and form requesting treatment information along with the decisional conflict questionnaire will be sent to patients.

Standard patient-physician counseling interaction

Andrew Stephenson, MD

This is a psychosocial/behavioral study and does not involve administration of any treatment or diagnostic procedures. We will use a randomized trial to test the hypothesis that a decision analysis model that provides individualized estimates of quality-adjusted disease-free survival for each of the treatment options for clinically localized prostate cancer will lead to higher quality treatment decisions congruent with a patient's values leading to improved decisional regret and treatment satisfaction. In this trial, all patients would be evaluated at baseline for their utilities for various clinically important health states. The control arm will receive counseling regarding treatment options using standard patient-physician interactions and nomogram-predicted probabilities of treatment outcome for the various treatment options and they will be unaware of the decision analysis recommendation. The treatment arm would be counseled using standard patient-physician interactions and they would also be provided with a personalized treatment recommendations based on the decision analysis model prior to treatment selection. The primary endpoint of this study will be regret-free survival at 2 years after treatment. There will be a 1:1 randomization. A random permuted design will be used to assure approximate balanced number of patients in the two groups over time.

Following institutional review board approval for this study and after informed consent from patients is obtained, men referred to our institution for treatment of clinically localized prostate cancer will be interviewed at baseline following diagnosis but prior to making a treatment decision, by a research study coordinator whom we will train in utility assessment. At that initial interview, the patient's utilities will be assessed, in a private consultation room, for each important post-treatment health state that he potentially may enter. The states we would assess include living with untreated prostate cancer, impotence, urinary dysfunction, bowel dysfunction, rising PSA following definitive local therapy, and metastatic prostate cancer. We will also record characteristics of the patient's disease (pretreatment serum PSA, clinical stage, biopsy Gleason grade), demographics (age, race, level of education, employment, marital status) and comorbidity. Patient-reported urinary, bowel, and sexual function/bother will be assessed at baseline using a short form version of a 48-item validated HRQOL instrument for localized prostate cancer. All patient information will be entered into a secure, HIPAA-compliant database accessible only to the principal investigator, research study coordinator(s), data manager, and biostatistician. All patient identifying information will be removed prior to data analysis and will not be included in any publication or presentation that results from this study. For all patients, the quality-adjusted disease-free survival for each treatment modality will be calculated using the decision analysis model. For the decision analysis arm of the trial, this information will be conveyed to the patient and the physician prior to treatment decision. These patients will also receive standard treatment counseling. For the control arm, both patients and physicians will be unaware of the decision analysis recommendation and the patients will receive standard treatment counseling alone. After the patient has made a treatment decision he will be given a short questionnaire to assess decisional conflict. If after one month no treatment decision information is available, a letter and form requesting treatment information along with the decisional conflict questionnaire will be sent to patients. At 6, 12, and 24 months following the treatment decision, the patient will be sent a brief validated questionnaire which will measure his regret of treatment choice, treatment satisfaction, decisional conflict and current health state utility using validated instruments. A short form version of a 48-item validated questionnaire will also assess his HRQOL for urinary, bowel and sexual function/bother domains at these time intervals. Approximately two weeks after receiving each follow-up questionnaire and/or letter, a member of the study group will contact the patient by telephone if we have not received the completed questionnaire. S/he will inquire about any difficulties with the questionnaire and will remind the patient about sending it back.

The primary endpoint of this study (decisional regret) and secondary endpoints (treatment satisfaction, decisional conflict, and current health state utility) will be assessed by means of a patient-reported questionnaire using validated instruments assessed at 6, 12 and 24 months after randomization. A decision analysis model will be developed using a Markov modeling approach. Using Treeage Data® pro suite, the model will incorporate cancer outcomes, treatment-related morbidity probabilities derived from nomograms, and patient-specific utilities to estimate the quality-adjusted disease-free survival for each treatment option. In the model, all patients will begin with localized prostate cancer with no evidence of metastases. A 6-month transition cycle will be used for the Markov model. Bootstrap simulation with replacement will be utilized to derive mean utilities and 95% confidence intervals. Sensitivity analyses will be performed by varying the disease progression rates and utilities within their 95% confidence intervals. To investigate if the decision analytic model, compared to standard interactions alone, will influence treatment choice and lead to higher quality treatment decisions that are congruent with a patient's values, an intent-to-treat analysis will be conducted on patients who did and did not receive the decision analysis recommendation with decisional regret as the primary endpoint. In a planned secondary analysis, we will analyze both arms of our trial and test the hypothesis that a patients who chooses a treatment strategy that did not appear to maximize his quality-adjusted disease-free survival (i.e. not the one the decision analysis would have yielded) will be at increased risk of regret. This will be conducted by identifying patients in both arms who choose the treatment that is also recommended by the decision model. The probability of selecting the decision analytic treatment strategy (which is also the probability of selecting the highest quality treatment decision congruent with a patient's values) will be investigated using a logistic regression model with covariates that include treatment arm, an indicator variable to define patients whose baseline treatment choice matched the decision analysis model, an interaction between the treatment arm and this indicator variable, as well as other clinically relevant baseline covariates and two way interactions. Testing for an interaction between treatment arm and the indicator variable will allow us to test if the effect that knowledge of the decision analytic model has on the probability of selecting the highest quality treatment decision is different for patients whose baseline treatment choice matched the decision analysis model compared to patients whose baseline treatment choice did not match the decision analysis model. Each patient will also have the following outcomes measured at 6 months, 12 months, and 24 months following their treatment: decisional regret, decisional conflict, treatment satisfaction, health state utility score, and HRQOL for urinary, bowel, and sexual function domain scores. All scores will be standardized such that each patient's score is between 0 and 100. Baseline decisional regret scores, informed decision scores, and treatment satisfaction scores will be set at 100, indicating no decisional regret, a high degree of feeling as though an informed decision was made, and high treatment satisfaction. Scores for health state utility and HRQOL domains will also be obtained at baseline. Based on each patient's final treatment choice, we will also calculate the difference between the number of quality adjusted life years based on the decision analysis model and the final treatment choice.

For each response, separate linear mixed models that include both fixed and random effects will be applied. To meet the distributional assumptions of this model, responses may be transformed prior to model fitting. Fixed effects that will be included in the model are clinically relevant baseline and time dependent covariates and two way interactions as well as linear or quadratic time trends. In particular, a covariate for treatment arm, an indicator variable to define patients who chose the decision analytic model based treatment choice, and an interaction between these two variables will be included. In this case, the interaction will allow us to test if the effect that knowledge of the decision analytic model has on various responses is different for patients who chose the decision analytic model treatment choice compared to patients who did not chose the decision analytic model treatment choice. A covariate for the difference between the number of quality adjusted life years based on the decision analysis model and the final treatment choice and an interaction between this variable and the treatment arm indicator variable will also be included in the model to examine if the effect that knowledge of the decision analytic model has on various responses is effected by the theoretical degree of mistake. To fully account for the variation in subject specific trajectories over time, a random intercept will be included in this model although linear and quadratic random effects will also be considered if appropriate. In addition, the residual covariance structure for each model will also be investigated to avoid misspecification and invalid inferences. In particular, correct specification of the covariance structure will be investigated using different ways to model the measurement error (due to variation in the measurement of the response) and serial correlation (due to decreasing correlation between measurements over time). For instance, structures for serial correlation will be investigated using a semi-variogram. Although the problem of a misspecified covariance structure can and will be avoided by using a robust variance estimator when making inferences about the fixed effects of interest based on the marginal model, misspecification also leads to an inability to properly account for the effect of missing data, a common occurrence in longitudinal studies. Note that once an appropriate model is fit to each response of interest, inference regarding the fixed treatment and covariate effects on the response will be based on marginal models using the robust variance estimator to protect against model misspecification of the covariance structure. Statistical significance of fixed effects will be based on a 0.05 significance level. As this study is exploratory, no attempt will be made to account for multiple comparisons.

As discussed previously, missing data is a common problem in longitudinal studies. Typically, patients who drop out of the study are not comparable to patients who remain in the study at all times. Consequently, the likelihood of dropout is correlated with the underlying unobserved data. To account for this problem, pattern mixture models will also be fit in addition to the previous models that ignore the effect of missing data on resulting estimates. Pattern mixture models are based on fitting separate linear mixed model to each of the seven dropout patterns that can occur in the data such that a separate time trend is estimated for each pattern. The marginal treatment effect is then calculated by a weighted average of the pattern-specific treatment effects, with weights given by the probability of occurrence of the various patterns. Because the estimated marginal treatment effects rely on the extrapolation of fitted average profiles to time points where data is not observed, sensitivity analyses will also be performed to examine the robustness of the results to alternative assumptions. For instance, rather than estimating a separate time trend for each pattern, the model could be simplified so that drop-out pattern is used as a covariate in the model. In this case, the time trend within a pattern is unstructured but parallel across patterns. If estimated marginal treatment effects agree among the different models that are investigated, this will suggest that the results are not artifacts of the particular model used to account for dropout.

Treatment Decision Analysis Model for Prostate Cancer: A Randomized Trial

HRQOL is a 48-item scale which measures quality of life in the domains of urinary, bowel, and sexual function. A short version of this scale will be used during follow-up. All scores will be standardized to a 0-100 scale where higher scores indicate greater quality of life.

To see if a decision analysis model that considers individualized predictions of cancer outcome, treatment-related morbidity, and patient-specific values for clinically important health states leads to higher quality treatment decisions patients will take a validated four item questionnaire which is standardized to a 0-100 point scale where higher values indicate less decisional regret. Scores will be compared between study arms.

A patient reported three item questionnaire scored on a 0-100 scale where 100 equals no decisional regret will be used to calculate decisional conflict. Scores will be compared between study arms.

Treatment satisfaction will be assessed on a 0-100 scale using a validated five item questionnaires where higher scores indicate more satisfaction. Scores will be compared between study arms.

Health state utility will be measured using validated questionnaires on a 0-100 scale where higher scores indicate more utility.

Case Comprehensive Cancer Center

Pelvic radiotherapy

* 46 Gy in 23 fractions of 2 Gy.
* prostate only-boost up to 66 Gy

Radiotherapy:

* 46 Gy in 23 fractions of 2 Gy.
* prostate only-boost up to 66 Gy

Associated with hormonal therapy by degarelix:

* beginning in parallel to radiotherapy for 6 months
* First dose of 240 mg
* Maintenance dose of 80 mg

First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)

Degarelix

46 Gy in 23 fractions Prostate only-boost up to 66 Gy

Pelvic Radiotherapy

Igor LATORZEFF

Laurent SALOMON

Paul SARGOS

Emmanuel MEYER

The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.

Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy.

122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme:

* Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy
* Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months

Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy

A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Biochemical recurrence was defined as a PSA \> nadir + 0.4 ng / mL confirmed by a second PSA\> nadir + 0.4 ng / mL in elevation.

The clinical recurrence will be defined by the discovery of a local recurrence in rectal examination, the appearance of metastases by imaging or biopsy, or clinical manifestation associated with malignant disease without elevated PSA but with histological documentation or imaging.

Ferring Pharmaceuticals

UNICANCER

Short-course Hypofractionated Once-weekly Radiation Therapy: 35Gy in 5 fractions delivered once a week.

Eligible patients will be treated with a radiation regimen of 35 Gy in 5 fractions delivered at one fraction per week at 7 day intervals. The dose of radiotherapy is based on the consensus alpha beta ratio of 1.5.

Short-course Hypofractionated Once-weekly Radiation Therapy

Indranil Mallick, MD

Hypofractionated external beam radiotherapy has been clinically used for localized prostate cancer in view of the low estimated alpha/beta ratio of prostate cancer cells. Moderate fraction sizes of \<4Gy per fraction has been investigated in several phase II/III studies and has been found to be well tolerated with comparable biochemical control in comparison with standard fractionated dose-escalated regimens. Fraction sizes of \> 4 Gy has also been investigated in single center studies. However, its toxicity and disease control outcomes is less well known. In this Phase I/II single arm study the investigators aim to treat non-metastatic prostate cancer with stageT1-T4N0M0 and Prostate Specific Antigen (PSA) \<60 ng/ml to a regimen of 35Gy in 5 fractions delivered once a week with a view to determine acute toxicity, biochemical control with PSA and late toxicity.

There is robust evidence to suggest that prostate cancers are slow growing with long tumor doubling times. Evidence accumulated from reported results of several thousands of patients suggest that unlike epithelial malignancies, the alpha/beta ratio for prostate cancer is low, in the range of 1.5 compared to 10. From the radiobiological standpoint, this means that instead of conventional daily fraction sizes of 1.8-2Gy, prostate cancer will be equally well if not better approached with larger fraction sizes. Based on this derivation several single arm and randomized studies have been started. Some have already been reported. They show quite uniformly that hypofractionated radiotherapy using fraction sizes of 2.6-3.1 Gy/fraction with appropriate modifications in the total dose is safe and effective. Therefore the paradigm of radiotherapy treatment of prostate cancer is shifting from 37-40Fractions delivered over 7-8 weeks to shorter courses delivered in 20-28fractions delivered over 4-5 weeks.

Taking this approach further it has been hypothesized that the schedule may be modified further and the total number of treatments can be reduced to 4-7 fractions delivered in a spaced schedule over 2-5 weeks. There are already 6-7 published reports of non-randomized cohorts treated with such schedules delivered using Image Guided Intensity modulated Radiation Therapy (IG-IMRT) or stereotactic radiotherapy (SBRT) techniques for localized risk cancers. Preliminary results from these studies show excellent safety and efficacy. These results have considerable implications. If the treatment of prostate cancer can be safely and effectively truncated from 37-40 fractions over 8 weeks to only 4-7 treatments delivered over 2-5 weeks, it results in better patient convenience, compliance, cost savings and also a significant sparing of healthcare resources. All of these are of great importance in countries like India.

The short course hypofractionated schedules have so far been mainly tried in selected risk groups, and have not previously been used in India. The investigators intend to perform a phase I/II study to test the safety and efficacy of a schedule of once weekly hypofractionated radiotherapy. The study population will be 30 patients with localized prostate cancer (T1-T4N0M0) with a PSA \<60 ng/ml. The patients will receive image-guided radiotherapy (IGRT) delivering 5 fractions of 7Gy at weekly intervals. Androgen deprivation therapy will be done according to standard criteria based on risk stratification. The primary endpoint of this study is the incidence of acute grade 2 or more side-effects. The secondary endpoints will be biochemical control at 3 years and late grade 2 side-effects at 2 years. Side effects will be monitored according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4. Quality of life assessments will be done using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and PR25 questionnaires at baseline, treatment completion, 3 and 6 months post treatment.

If found safe and effective, this schedule of treatment will lead to phase I studies comparing this schedule with standard fractionation or more moderate hypofractionation schedules.

Phase I/II study of radiotherapy fractionation

Short Course Radiotherapy for Localized Prostate Cancer

Phase I/II Study of Short-course Hypofractionated Once-weekly Radiation Therapy (SHORT) for Localized Prostate Cancer

Once appropriate authorities approach and once clearance of local authorities is received, data could be shared

To determine the rates of acute gastrointestinal and genitourinary toxicity according to NCI CTCAE v4.0.

To determine the incidence of biochemical control (with measurement of prostate specific antigen) at 3 years. Failure is defined by the Phoenix criteria of nadir PA value in ng/ml + 2 ng/ml.

the incidence of late gastrointestinal toxicity according to NCI CTCAE v4.0 as assessed at 3 years.

To determine the incidence of late genitourinary toxicity according to NCI CTCAE v4.0 as assessed at 3 years.

To evaluate the quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 questionnaire and measure the impact of this regimen of radiotherapy on the global health status, functional scales and all general symptom scores on a scale of 0 to 100 (higher score in global and functional scales representing better quality-of-life, while higher sores on symptom scales representing more symptoms). A scale difference of 10 or more would be considered clinically meaningful in any domain.

To evaluate the quality of life using the PR25 questionnaire and measure the impact of this regimen of radiotherapy on the prostate cancer related urinary, bowel and hormonal therapy related scores on a scale of 0 to 100 (higher score on symptom scales representing more symptoms). A scale difference of 10 or more would be considered clinically meaningful in any domain.

Tata Medical Center

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Anesthetics

Anesthetics, Local

Prilocaine

Sodium Channel Blockers

Diuretics, Potassium Sparing

transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure % 2 lidocaine hydrochloride gel instilated into the rectum for local anesthesia

transrectal ultrasound guided prostate biopsy was performed with intrarectal lidocaine gel anesthesia: 10 minutes before the procedure transrectal ultrasound guided 10 ml prilocaine and serum physiologic blend (5ml %2 prilocaine and 5 ml serum physiologic) injected separetly 5ml right and 5ml left junction between the prostate base and seminal vesicle.

intrarectal lidocaine gel

periprostatic local anesthetic application

periprostatic nerve blockade

mustafa z temiz

Transrectal ultrasound guided prostate biopsy (TRUS-Bx) is the gold standard method for prostat cancer diagnosis. Cancer detection rate is an important issue in TRUS-Bx. Effective biopsy protocol is necessary to enhance cancer detection rate during the procedure. Patient tolerance may improve the protocol effectiveness and quality.

Adequate patient tolerance with optimal local anesthesia may enhance cancer detection rate in TRUS-Bx.

In transrectal ultrasound guided prostate biopsy ultrasound's probe manipulation is necessary for effective biopsy. Patient discomfort and pain frequently occurs with manipulation of probe during transrectal ultrasound guided prostate biopsy and this situation may qualify of the achievement of this procedure.

In this study, we aimed to describe the impact of different two local anesthesia types on cancer detection rate in transrectal ultrasound guided prostate biopsy.

Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy

Bagcilar Training and Research Hospital

principal investigator

A total of 65 consecutive newly diagnosed prostate cancer patients with 2013 NCCN high risk category will be consecutively enrolled in a prospective phase II trial on Carbon Ions Boost Followed by Pelvic Photon Radiotherapy .

The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, at the Division of Radiation Oncology of the European Institute of Oncology (IEO), Milan, Italy, or at the Fondazione IRCCS Istituto Nazionale Tumori (INT), Milan, Italy. The treatment will include a boost phase on the whole prostate with carbon ions performed at CNAO followed by a pelvic photon RT, with IMRT performed with conventional fractionation of 1.8 Gy per fraction up to 45 Gy to the pelvic lymph nodes, prostate and seminal vesicles. The total dose prescribed to the prostate boost with carbon ions will be of 16.6 GyE in 4 fractions (4.15 GyE/fraction).

Carbon Ions Boost Followed by Pelvic Photon Radiotherapy

Roberto Orecchia, MD

The aim of this research project is to test the feasibility and safety of a new treatment schedule for high risk prostate cancer that allows the administration of high doses to the prostate tumor with a mixed beam approach of carbon ions boost followed by pelvic IMRT.

The present research project aims to improve the current treatment for high risk prostate cancer, evaluating the safety and feasibility of a new RT scheme of a carbon ions boost followed by pelvic photon RT.

A total of 65 consecutive patients will be enrolled in a prospective phase II trial. The patients will be enrolled either at Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, at the Division of Radiation Oncology of the European Institute of Oncology (IEO), Milan, Italy, or at the Fondazione IRCCS Istituto Nazionale Tumori (INT), Milan, Italy.

The treatment will include a boost phase on the whole prostate with carbon ions performed at CNAO followed by a pelvic photon IMRT performed with conventional fractionation of 1.8 Gy per fraction up to 45 Gy to the pelvic lymph nodes, prostate and seminal vesicles. All the patient data will be collected in a common database accessible from the 3 Institutions.

At CNAO, carbon ions beam is available for patient treatment since 2011. In comparison to the Japanese Center NIRS, the facility relies on active beam delivery using the rasterscan technique, which offers not only physical advantages with better sparing of normal tissues in the entrance channel, but also enables biologic plan optimization. The facility has the same equipment as the Carbon Ion Treatment Center in Heidelberg, Germany. At CNAO, 3D - 4D patient target localization is verified at each fraction by integrating orthogonal X-ray images and 3D real time optical tracking system.

At IEO and INT, the IMRT phase will be performed with the same treatment modality: volumetric-IMRT RapidArc by Varian Trilogy (IEO) and Varian DHX (INT) linacs, Varian Medical Systems, Palo Alto, CA, USA, with treatment based on the isocentric beam delivery, and pre-treatment image guidance for patient alignment via cone beam CT or portal imaging.

In phantom, quality assurance (QA) of each treatment will be performed before patient RT, in order to verify the consistency between calculated and delivered dose.

Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer

Toxicity and quality of life data will be prospectively assessed and analysed descriptively. Toxicities will be graded according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.0 and Radiotherapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) criteria. Inacceptable toxicity will be \> 3 patients with acute side effects grade 4, or \> 3 patients with late RTOG/EORTC, CTCAE side effects grade 4, or \> 3 patients with late RTOG/EORTC, CTCAE side effects grade 3, or any grade 5 toxicity.

Biochemical progression free survival will be measured from the beginning date of RT to the date of PSA elevation. PSA relapse is defined according to the Consensus Statement of the American Society of Radiation Oncology (ASTRO) as elevation of PSA levels nadir + 2 ng/ml and confirmed by one measurement

It will be considered pattern of failure relapse in the same prostate lobe, in other lobes, in lymph nodes, in other distant sites.

Associazione Italiana per la Ricerca sul Cancro

European Institute of Oncology

The patients will be treated with extreme hypofractionated radiotherapy with the dose delivery system that will result most fit at the in-silica study. Simultaneous Integrated Boost (SIB) technique will be applied to deliver a total dose of 36.25 Gy in 5 fractions (over 10 days) to the whole prostate (7.25 Gy/fraction) and 37.5 Gy to the dominant intraprostatic lesion DIL (7.5 Gy/fraction), profiting of the high sensibility of prostate cancer to high dose/fraction. Several strategies will be applied in order to reduce the dose to the surrounding organs at risk.

External beam radiotherapy

BARBARA A JERECZEK, MD PhD

The present research project aims to improve the current treatment for prostate-confined tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy schedule administered with one of the best available dose delivery systems. The study will include 2 sub-studies (in-silica and clinical study) and 4 tasks.

Approximately 70% of men with newly diagnosed prostate cancer feature organ-confined disease. Conventional treatment options for prostate-confined cancer include radical prostatectomy, external beam radiation therapy, brachytherapy and active surveillance. All currently available treatments have comparable toxicity risk and high social and economic impact, hence the best treatment option has not been defined yet. In the radiation oncology field the gold standard for prostate cancer management is 7-8 weeks intensity modulated radiotherapy (IMRT), which can be delivered with the latest generation of accelerators providing modulated arc delivery (eg. RapidArc™, Varian) or with newly developed machines such as the Vero system (BrainLab AG - Mitsubishi Heavy Industries Ltd). The present research project aims to improve the current treatment for prostate confined tumor, evaluating the best strategy to deliver a very-short hypofractionated radiotherapy scheme. In the first part of this AIRC grant an in-silica study will be performed on 10 test prostate cancer patients, with comparative competitive treatment plans with the state of the art treatment options for prostate cancer: the Vero system, the RapidArc system, the Cyberknife (all available at the European Institute of Oncology IEO, Milan, Italy), and protontherapy (available at the Centre of Adrotherapy, in Pavia, Italy). This dosimetric comparison will be performed in order to define the technique that provides the maximum target coverage with the minimum dose to the surrounding organs at risk (OARs) to be used to perform the clinical trial that will follow within this AIRC grant. After performing the in-silica study, 65 newly diagnosed prostate cancer patients with 2011 National Comprehensive Cancer Network (NCCN) risk category ranging from very low to intermediate but not undergoing hormonal treatment, will be consecutively enrolled in a prospective phase II trial. The patients will be treated at the Division of Radiation Oncology of the IEO, with the dose delivery system that will result most fit at the in-silica study. Simultaneous Integrated Boost (SIB) technique will be applied to deliver a total dose of 36.25 Gy in 5 fractions (over 10 days) to the whole prostate (7.25 Gy/fraction) and 37.5 Gy to the dominant intraprostatic lesion DIL (7.5 Gy/fraction), profiting of the high sensibility of prostate cancer to high dose/fraction. Several strategies will be applied in order to reduce the dose to the surrounding OARs. In order to define the localization of the DIL, multiparametic magnetic resonance imaging (MRI) of the pelvis will be performed (with spectroscopy, diffusion weighted and perfusion acquisitions), and fused with computed tomography (CT) scan. In-room image-guidance will be applied at each treatment section, in order to minimize uncertainties in intra and inter-fraction prostate localization. At the end of the radiotherapy course, each patient will be followed-up, in order to assess the treatment safety and effectiveness in terms of early and late toxicity, and tumor control. A sampling from the prostate tumor tissue for biological study will be taken for microarray analysis. The expression of specific markers of radiosensitivity and radioresistance will be investigated.

Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion

The primary outcome is the acute toxicity according to the validated scale Radiotherapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG / EORTC). It will measure the proportion of patients who experience at least one event of acute toxicity of grade 3 or 4 according to the scale RTOG / EORTC) as the maximum value of toxicity during radiation treatment or within one month after the completion of radiotherapy.

late toxicity according to Scala CTCAE v4.0 toxicity criteria and scale RTOG / EORTC

assessed in terms of

* biochemical progression free survival (biochemical relapse, i.e. rising PSA)
* pattern of relapse
* clinical progression free survival (including local or distant recurrence)
* overall survival

Rare Diseases

Kennedy Disease

Reproductive Control Agents

Androgens

Mifepristone

Contraceptive Agents

Contraceptives, Oral

Contraceptive Agents, Female

Contraceptives, Postcoital

Hormones

Hormone Antagonists

Contraceptive Agents, Hormonal

Mary-Ellen Taplin, MD

The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.

Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.

At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.

After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.

Mifepristone (RU-486) in Androgen Independent Prostate Cancer

A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer	NCT02342626	Adenocarcinoma ...	Dashboard	40 Years - 85 Years	University of Rochester
Treatment Decision Analysis Model for Prostate Cancer: A Randomized Trial	NCT02024685	Adenocarcinoma ... Adenocarcinoma ... Adenocarcinoma ... Adenocarcinoma ...	Personalized Tr... Standard patien...	-	Case Comprehensive Cancer Center
Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy	NCT01994239	Adenocarcinoma ...	Degarelix Pelvic Radiothe...	18 Years -	UNICANCER
Short Course Radiotherapy for Localized Prostate Cancer	NCT03518853	Adenocarcinoma ...	Short-course Hy...	18 Years -	Tata Medical Center
Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy	NCT01994239	Adenocarcinoma ...	Degarelix Pelvic Radiothe...	18 Years -	UNICANCER
Impact of Local Anesthesia Type on Cancer Detection Rate in Transrectal Ultrasound Guided Prostate Biopsy	NCT02025361	Adenocarcinoma ...	intrarectal lid... periprostatic n...	-	Bagcilar Training and Research Hospital
Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer	NCT02342626	Adenocarcinoma ...	Dashboard	40 Years - 85 Years	University of Rochester
Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer	NCT02672449	Adenocarcinoma ...	Carbon Ions Boo...	18 Years -	European Institute of Oncology
Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion	NCT01913717	Adenocarcinoma ...	External beam r...	18 Years -	European Institute of Oncology
Mifepristone (RU-486) in Androgen Independent Prostate Cancer	NCT00140478	Prostate Cancer Adenocarcinoma ...	Mifepristone	18 Years -	Dana-Farber Cancer Institute
Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer	NCT02672449	Adenocarcinoma ...	Carbon Ions Boo...	18 Years -	European Institute of Oncology
Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion	NCT01913717	Adenocarcinoma ...	External beam r...	18 Years -	European Institute of Oncology

Spots Global Cancer Trial Database for adenocarcinoma of prostate