Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Leuprolide

Goserelin

Bicalutamide

Hormone Antagonists

Antineoplastic Agents, Hormonal

Androgens

Androgen Antagonists

Intervention: Radiation therapy delivered to a total dose of 6600 centigray (cGy) at 200 cGy/fraction (fx) once daily using a 3-D conformal radiation technique (3-D CRT). The volume of radiation will encompass the prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement. Hormonal therapy will be required for patients with "high risk" disease (both the adjuvant and salvage groups). For patients with "low risk" disease, hormonal therapy will be as per standard of care. Hormonal therapy will typically begin 2 months prior to radiation and continue for a total of 6 months. Hormonal therapy regimen will consist of Casodex (50 mg/day po for 6 months) and Zoladex (10.8 mg sc once every 3 months x 2 injections) or Lupron (22.5 mg im once every 3 months x 2 injections) to start on day 1 once the subject has been enrolled to the clinical trial.

Intervention: Radiation therapy delivered to a total dose of 6600 centigray (cGy) at 200 cGy/fraction (fx) once daily using intensity modulated radiation therapy (IMRT). The volume of radiation will encompass the prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement. Hormonal therapy will be required for patients with "high risk" disease (both the adjuvant and salvage groups). For patients with "low risk" disease, hormonal therapy will be as per standard of care. Hormonal therapy will typically begin 2 months prior to radiation and continue for a total of 6 months. Hormonal therapy regimen will consist of Casodex (50 mg/day po for 6 months) and Zoladex (10.8 mg sc once every 3 months x 2 injections) or Lupron (22.5 mg im once every 3 months x 2 injections) to start on day 1 once the subject has been enrolled to the clinical trial.

Radiation delivered after surgery to remove the prostate, using 3-D Conformal Radiation Therapy. Radiation will be delivered to prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement.

The total dose of radiation will be 6600 centigray (cGy) at 200 cGy/fraction (fx) given once daily .

3-D Conformal Radiation Therapy

Radiation delivered after surgery to remove the prostate, using Intensity Modulated Radiation Therapy. Radiation will be delivered to prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement.

The total dose of radiation will be 6600 centigray (cGy) at 200 cGy/fraction (fx) given once daily .

Intensity Modulated Radiation Therapy

Hormonal Therapy (6 Months): Required for "High Risk" Groups, and as per Standard of Care for "Low Risk" Groups.

Hormonal therapy protocol regimen for the high risk "adjuvant" and "salvage" groups will consist of Casodex (50 mg/day po for 6 months) and Zoladex (10.8 mg subcutaneously once every 3 months x 2) or Lupron (22.5 mg given intramuscularly once every 3 months x 2 injections or 7.5 mg IM q once monthly x 6) to start on day 1 of the clinical trial.

Hormonal therapy will typically begin 2 months prior to radiation and continue for a total of 6 months.

Casodex, Zoladex , Lupron

Parvesh Kumar, MD

Compare the incidence of acute rectal, bladder and other acute toxicities between 3-D Conformal Radiation Therapy (RT/CRT) and Intensity Modulated Radiation Therapy (IMRT) in Post-Prostatectomy Prostate Cancer Patients treated with post-operative radiation therapy

In 2015, the American Cancer Society estimates that almost 220,800 men are expected to be diagnosed with prostate cancer, and about 27,540 men are expected to die of this disease. Curative treatment of prostate cancer consists of either surgery (i.e., radical prostatectomy) or radiation therapy (RT). Approximately one-third of men who undergo a prostatectomy will require post-operative adjuvant or salvage RT.

During the last 2 decades, the techniques used to deliver RT have evolved from 2-D RT in the 1980's and early 1990's, to 3-D conformal RT (3-D CRT) in the late 1990's, to intensity modulated radiation therapy (IMRT) within the last decade.

To date, no randomized prospective head to head comparison between 3-D CRT and IMRT to assess toxicity differences has ever been conducted in the treatment of post-prostatectomy prostate cancer patients. Retrospective evidence suggests comparable acute and late genitourinary (GU) and gastrointestinal (GI) toxicity. In addition, no postoperative randomized trials investigating hormonal therapy (HT) and RT have been published, but three prior phase III studies of men treated definitively for prostate cancer, one by the Radiation Therapy Oncology Group (RTOG) (86-10), one by investigators at Harvard, and one by the Trans-Tasman Radiation Oncology Group, concluded that neoadjuvant and concurrent short-term hormonal therapy (i.e., 4-6 months) RT reduces cause-specific mortality compared with RT alone.

The purpose of this study is to estimate, correlate, and compare the incidence of acute rectal, bladder and other acute toxicities between 3-D CRT and IMRT in prostate cancer patients treated with post-operative radiation therapy, to quantify, compare, and correlate the dose volume histogram (DVH) doses (e.g., Vmean, Vmedian, V25, V50, V75) to the surrounding critical organs (i.e., rectum and bladder) between 3-D CRT and IMRT, and to measure, compare, and correlate the quality of life scores of participants using the EORTC Quality of Live Questionnaires (QLQ), called "QLQ-C30" and "EPIC-26". These survey instruments will measure quality of life differences during the study; the comparison will be done between 3-D CRT and IMRT treatment arms.

Hormonal therapy will also be required for patients with high risk disease (both the adjuvant and salvage groups) and as per standard of care for patients with low risk disease, but is not explored in this study.

There are 2 arms (groups) in this study:

Arm 1: 3-D Conformal Radiation Therapy (plus hormonal therapy)

Arm 2: Intensity Modulated Radiation Therapy (plus hormonal therapy)

Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients

Phase II Randomized Clinical Trial Comparing 3-D Conformal Radiation Therapy (RT) vs. Intensity Modulated Radiation Therapy in Post- Prostatectomy Prostate Cancer Patients

Acute rectal, bladder and other toxicity rates will be estimated and 95% exact binomial confidence intervals will be calculated. Toxicity will be measured via analysis of patient adverse events (physiological parameter). Adverse events will be scored using NCI Common Toxicity Criteria for Adverse Events v 4.0.3 (June 14, 2010). A two-sample binomial test will be used. This time point is an interim toxicity monitoring event designed to protect against the unlikely event of significantly more grade 2 or higher toxicities in one treatment vs. the other. If at any point, after the first 10 patients in each arm, the grade 2 or higher acute toxicity rate in either arm is more than double the grade 2 or higher acute toxicity rate in the other treatment arm, enrollment will be suspended and review of safety profiles conducted. The PI and Data Safety Monitoring Committee will then either modify the protocol or close the study to accrual.

After safety issues, if any, have been resolved and study continued, the TOTAL of ALL 100 subjects (50 in each treatment arm) will be measured thus: Acute rectal, bladder and other toxicity rates will be estimated and 95% exact binomial confidence intervals will be calculated. To compare these rates between 3-D CRT and IMRT treatment arms, a two-sample binomial test will be used. Toxicity will be measured via analysis of patient adverse events (physiological parameter). Adverse events will be scored using NCI Common Toxicity Criteria for Adverse Events v 4.0.3 (June 14, 2010).

To quantify and compare the dose volume histogram (DVH) doses (e.g., Vmean, Vmedian, V25, V50, V75) to the surrounding critical organs (i.e., rectum and bladder) between 3-D CRT and IMRT, a two-sample t-test will be used.

To measure and compare participants' quality of life, overall scores will be obtained from participants via the EORTC QLQ C-30 survey instrument. This tool is used for each participant's measure of their own quality of life with this cancer. A two-sample t-test will then be used to make the comparison between treatment arms.

To measure and compare participants' quality of life, overall scores will be obtained from participants via the EPIC-26 survey instrument. This tool is used for each participant's measure of their own quality of life with this cancer. A two-sample t-test will then be used to make the comparison between treatment arms.

University of Kansas Medical Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days

Boon Chua

Hypothesis:

In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.

This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins.

This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival, and overall survival.

Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery.

Secondary objectives:

* To assess the acute and long term toxicity of APBI using 3D CRT.
* To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT.
* To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT.
* To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT.

Accelerated Partial Breast Irradiation for Early Breast Cancer

A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.

Peter MacCallum Cancer Centre, Australia

Trans Tasman Radiation Oncology Group

Conformal radiation therapy External beam radiation therapy

Active monitoring of prostate specific antigen levels and disease surveillance

Radical prostatectomy

Conformal radiation therapy, external beam

Conformal radiation therapy

Active monitoring of Prostate specific antigen levels and disease surveillance

Active monitoring

Freddie C Hamdy

RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.

OBJECTIVES:

* To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
* To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
* To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function.
* To estimate the resource use and costs of detection, treatment, and follow-up.
* To compare costs and outcomes of treatment in terms of survival and health-related quality of life.
* To collect samples suitable for basic science research (ProMPT study).

OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (\< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients	NCT02678520	Prostate Cancer	3-D Conformal R... Intensity Modul... Casodex, Zolade...	18 Years -	University of Kansas Medical Center
Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients	NCT02678520	Prostate Cancer	3-D Conformal R... Intensity Modul... Casodex, Zolade...	18 Years -	University of Kansas Medical Center
Accelerated Partial Breast Irradiation for Early Breast Cancer	NCT00418210	Breast Cancer	Accelerated par...	50 Years -	Trans Tasman Radiation Oncology Group
Prostate Testing for Cancer and Treatment	NCT02044172	Prostate Cancer	Radical prostat... Conformal radia... Active monitori...	50 Years - 69 Years	University of Oxford

Spots Global Cancer Trial Database for conformal radiation therapy