Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.

Laboratory Biomarker Analysis

Proton Beam Radiation Therapy

Quality-of-Life Assessment

Steven J Frank

This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed treatment regimens at 2 years post-treatment.

SECONDARY OBJECTIVES:

I. Estimate the change in health related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire.

II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific antigen (PSA) at 5 years.

V. Determine the rate of local failure by biopsy of the prostate when objective tests, prostate-specific antigen (PSA), magnetic resonance imaging (MRI), digital rectal exam (DRE), suggest relapse.

OUTLINE:

Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.

After completion of study treatment, patients are followed up every 6-12 months for 24 months and then annually until month 60.

Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma

The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.

Rates of acute toxicity will be assessed.

Rate of late toxicity will be determined.

Incidence of rising PSA will be assessed.

Rate of local failure by biopsy will be evaluated.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Stereotactic Body Radiation Therapy

Nicholas Nickols, MD, PhD

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

PRIMARY OBJECTIVES:

I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.

SECONDARY OBJECTIVES:

I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite \[EPIC\] and International Prostate Symptom Score \[IPSS\] questionnaires).

II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.

III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.

OUTLINE:

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.

Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy

Based on the Common Terminology Criteria for Adverse Events (CTCAE) v4. Grade refers to the severity of the adverse event. Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening. Grade 0 refers to absence of an adverse event (ae).

The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing a better quality of life.

The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.

Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT

Jonsson Comprehensive Cancer Center

Stereotactic Body Radiation Therapy (SBRT)

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Gleason grade assigned based on predominant pattern in biopsy + a second Gleason grade to the second most predominate pattern. The two grades are added together to determine the Gleason score. Assigned Gleason scores range from 6 - 10, with 6 being low grade or better and 10 is high grade or worse.

Gleason Grade

Primary tumor, regional nodes, metastasis (TNM) staging system: A system to describe the amount and spread of cancer in a patient's body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Larger numbers indicate worse indication.

CStage

Nicholas Nickols, MD

Treatment Stereotactic Body Radiotherapy (SBRT)

Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications

Genitourinary Toxicities

Gastrointestinal toxicities

Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities

Urinary Incontinence

urinary irritative/obstructive

Bowel

Sexual Function

Hormonal

Change in score from baseline at 12 months. Quality-of-Life Assessment: Ancillary studies

Mean change in EPIC-26 score from baseline to 12 months. Three patients dd not complete the QOL assessment and therefore were not included in the analysis.

Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.

Three patients dd not complete the QOL assessment and therefore were not included in the analysis.

Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.

CD11b

CD68

CD163

Post SBRT and Radical Prostatectomy (RP)

Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in macrophage subsets. Six participants had available paired biopsy cores and Radical Prostatectomy (RP) specimens for analysis.

Correlative Biomarker Analyses Using Tissue and Serial Blood Samples

CD3+CD8

CD3+CD4

CD4+FOXp3

Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in T cell. Six participants had available paired biopsy cores and RP specimens for analysis.

Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Overall Study

Symptoms and General Pathology

Disease Progression

All Drugs and Chemicals

Micronutrients

Antineoplastic Agents

Vitamins

Androgens

Hormones

Prolactin Release-Inhibiting Factors

Androgen Antagonists

Hormone Antagonists

Ascorbic Acid

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Estrogens, Conjugated (USP)

Estrogens

Antioxidants

Protective Agents

Trace Elements

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Vitamin C

Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen

Antiandrogen Therapy

Amar Kishan, MD

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To determine the efficacy of postoperative stereotactic body radiation therapy (SBRT) at a dose of 34 grays (Gy) in five fractions, as compared with historical control efficacy rates in patients who received conventionally fractionated postoperative radiotherapy.

II. To determine the toxicity of postoperative SBRT at a dose of 34 Gy in five fractions, both via physician-scored and patient-reported metrics.

SECONDARY OBJECTIVES:

I. To determine the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with magnetic resonance imaging (MRI)-guided radiotherapy.

II. To gather biomarkers that may elucidate predictors of increased efficacy or increased toxicity.

TERTIARY OBJECTIVES:

I. To compare toxicity profiles (both physician-scored and patient-reported) between patients treated utilizing a linear accelerator versus a tri-60Co teletherapy platform.

OUTLINE:

Patients undergo SBRT every other day (QOD) for 14 days. Patients may also receive androgen deprivation therapy (ADT) comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy

Comparative analysis will be performed to assess physician-scored toxicity profiles for treated utilizing a linear accelerator. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing a linear accelerator. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Comparative analysis will be performed to assess toxicity profiles with patients treated utilizing a linear accelerator. Chi-square test or Fisher's exact test will be used for qualitative toxicity measurements, while unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing an MRI-guided radiotherapy device. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.4 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT). The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically. One sample log-rank test will be used to test difference in BCRFS between intervention and historical control. The median BCRFS time will be calculated with 95% confidence interval. Summaries of the number and percentage of patients experiencing a biochemical recurrence will be provided.

Represented by the rates of acute (early, within 90 days of SBRT) and late (90 or more days after SBRT) genitourinary and gastrointestinal toxicity based on the Common Terminology Criteria for Adverse Events version 4.03. Adverse Events (AEs) and serious adverse events (SAEs) will be listed individually by patient.

Patient-reported toxicity outcomes represented by changes in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains on the Expanded Prostate Cancer Index-26 (EPIC-26) quality of life instrument (scored from 0-100 points for each domain, higher scores reflect worse symptom/bother severity.)

Patient-reported toxicity outcomes represented by changes in International Prostate Symptom Scores (IPSS) (scored from 0-35 points, higher scores reflect worse symptom/bother severity.).

Point estimate and the corresponding 95% confidence interval will be calculated for the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with MRI-guided radiotherapy.

Viewray Inc.

Immune System Diseases

Recurrence

Hypersensitivity

Anti-Infective Agents

Itraconazole

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Patients receive twice/day 300mg itraconazole (oral)

Pharmacological Study

Rahul Aggarwal, MD

This phase II trial studies how well itraconazole works in treating patients with biochemically relapsed prostate cancer. Itraconazole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine whether the proportion of patients who achieve a \>= 50% decline in serum prostate-specific antigen (PSA) after 12 weeks of protocol therapy with itraconazole dosed at 300 mg orally (PO) twice daily (BID) is superior to a historical control based upon the observed PSA response proportion in prior studies of non-castrating systemic therapy in men with biochemically relapsed hormone sensitive prostate cancer.

SECONDARY OBJECTIVES:

I. To determine the median time to PSA progression from the start of protocol therapy with itraconazole among men with biochemically relapsed prostate cancer.

II. To determine the median time to clinical progression measured from the start of protocol therapy with itraconazole among men with biochemically relapsed prostate cancer.

III. To determine the median metastasis-free survival measured from the start of protocol therapy in patients treated with itraconazole for biochemically relapsed prostate cancer.

IV. To determine the mean percent change from baseline after 12 weeks of protocol therapy compared with pre-treatment in PSA doubling time.

V. To characterize the safety profile of itraconazole in the biochemically relapsed hormone sensitive prostate cancer population, as graded by Common Toxicity Criteria (CTCAE) version 4.03. All adverse events will be tabulated by grade according to the worst grade experienced.

VI. To determine the mean steady-state itraconazole and hydroxy-itraconazole serum levels after 4 weeks of therapy with itraconazole.

Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer

Hedgehog Inhibition as a Non-Castrating Approach to Hormone Sensitive Prostate Cancer: A Phase II Study of Itraconazole in Biochemical Relapse

The number of patients with biochemically relapsed disease after prior definitive local therapy who achieve a ≥ 50% decline from baseline in serum PSA after 12 weeks of therapy with itraconazole, confirmed by repeat measurement at least 2 weeks later.

The mean percent change in PSA doubling time from pre-treatment to after 12 weeks of protocol therapy

PSA progression defined as: 1. If no PSA decline is observed on therapy, PSA progression will be defined as an increase in serum PSA \> 50% above the baseline PSA, and an absolute increase of \> 2 ng/mL above baseline, confirmed by repeat measurement at least 2 weeks later. 2. If PSA declines on therapy, PSA progression will be defined as an increase in serum PSA \> 50% above the nadir PSA on therapy, and an absolute increase \> 2 ng/mL above the nadir, confirmed by repeat measurement at least 2 weeks later. The probability distribution of the time to PSA progression will be estimated using the Kaplan-Meier product limit method measured from the start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.

Clinical progression will be defined as the first occurrence of either the development of metastases or initiation of non-protocol therapy, and will exclude PSA-only progression.

The probability distribution of the time to clinical progression will be estimated using the Kaplan-Meier product limit method measured from the time of start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.

The probability distribution of the time to first metastasis will be estimated using the Kaplan-Meier product limit method measured from the time of start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.

All patients who receive at least one dose of study drug will be analyzed for safety endpoints. All adverse events will be graded and classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4. Percentage of patients with grade 1 or higher, treatment-related adverse events based on the following vital sign assessments will be reported: blood pressure, pulse, respiration rate and temperature.

All patients who receive at least one dose of study drug will be analyzed for safety endpoints. All adverse events will be graded and classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4.. Percentage of patients with grade 1 or higher, treatment-related adverse events based on the following labs will be reported: potassium, sodium, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), Hematocrit, Hemoglobin, platelets, white blood cells, atypical lymphs, basophils, eosinophils, monocytes, neutrophils, blood urea nitrogen, and creatinine.

Descriptive statistics including the mean, standard deviation, and range of steady-state trough serum levels of itraconazole and its active metabolite hydroxy-itraconazole will be determined.

University of California, San Francisco

All patients who received at least one dose of study drug were analyzed for adverse events

Treatment (Itraconazole)

40-49 Years

50-59 Years

60-69 Years

70-79 Years

Age, Customized

Ethnicity (NIH/OMB)

Years since diagnosis of prostate cancer

Gleason grade ≤ 7 (low/intermediate grade)

Gleason grade > 7 (high grade)

Gleason grade is determined at the time of diagnosis based on pathology review of prostate cancer biopsy or surgical specimen. A higher Gleason grade (\> 7) is associated with a higher chance for disease recurrence and shorter long-term survival.

Gleason Grade at Time of Diagnosis

Time interval from biochemical relapse to study entry

PSA doubling time at the time of study entry

No evaluable data was collected from validated assay. Long term, metastatic disease status data was also not collected.

Number of Patients Who Achieve a Greater Than or Equal to 50% Decline in Serum Prostate Specific Antigen (PSA)

Mean Percent Change in PSA Doubling Time

Median Time to PSA Progression

Only 1 patient displayed clinical progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer	NCT01950351	Stage I Prostat... Stage II Prosta...	Laboratory Biom... Proton Beam Rad... Quality-of-Life...	18 Years -	M.D. Anderson Cancer Center
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery	NCT02830165	Stage I Prostat... Stage II Prosta... Stage III Prost...	Laboratory Biom... Quality-of-Life... Stereotactic Bo...	18 Years -	Jonsson Comprehensive Cancer Center
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery	NCT03541850	PSA Level Great... PSA Progression Stage I Prostat... Stage II Prosta... Stage III Prost...	Antiandrogen Th... Quality-of-Life... Stereotactic Bo...	18 Years -	Jonsson Comprehensive Cancer Center
Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer	NCT01787331	Prostate Adenoc... Recurrent Prost... Stage I Prostat... Stage II Prosta... Stage III Prost...	Itraconazole Laboratory Biom... Pharmacological...	18 Years -	University of California, San Francisco
PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance	NCT02326805	Stage I Prostat... Stage II Prosta...	Laboratory Biom... Placebo Adminis... Rilimogene Galv...	-	National Cancer Institute (NCI)
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery	NCT03541850	PSA Level Great... PSA Progression Stage I Prostat... Stage II Prosta... Stage III Prost...	Antiandrogen Th... Quality-of-Life... Stereotactic Bo...	18 Years -	Jonsson Comprehensive Cancer Center
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer	NCT01950351	Stage I Prostat... Stage II Prosta...	Laboratory Biom... Proton Beam Rad... Quality-of-Life...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for stage ii prostate adenocarcinoma ajcc v7