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

Androgens

Leuprolide

Hormones

Hormone Antagonists

Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months

Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)

Radiation

Leuprolide 45mg every 6 months for a total of 18 months

Androgen Suppression

Glenn Bauman, MD

This study will explore the combination of a stereotactic body radiation therapy (SBRT) approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for older men with high risk prostate cancer, or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

The purpose of this study is to examine the safety of a shorter course of radiation treatment combined wtih androgen deprivation therapy.

Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80 Gy over 7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant LHRH agonist) compared to a primary hormone therapy or radiation therapy alone in men with locally advanced/high risk disease. While this approach may be tolerable in fit individuals, this combination may not be well tolerated by frail individuals, or those who live at a distance who may find it difficult to attend for 7 weeks of radiation treatments. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy.

The combination of short course radiation and hormone therapy was explored in the FASTR trial. As part of the trial, patients received 12 months of hormone therapy with radiation treatment to the pelvic lymph nodes (dose of 25 Gy in 5 fractions, 1 fraction per week) concomitant with radiation treatment to the prostate (dose of 40 Gy in 5 fractions, 1 fraction per week). The study was discontinued due to toxicity. For the FASTR-2 study, these concerns are being addressed through the use of a lower total dose to the prostate (35 Gy in 5 fractions, 1 fraction per week). Given the uncertainty of the benefit of pelvic nodal radiation in prostate cancer, it was decided to omit the pelvic nodal radiation in the FASTR-2 study. In addition, given the recent evidence supporting the equivalence of 18 months of hormone therapy, compared to 36 months, it was decided to lengthen the duration of hormone therapy in the FASTR-2 study to 18 months (versus 12 months in the FASTR study).

Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2

Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria

Defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition

Measured using the Prostate Cancer Radiotherapy questionnaire

Genitourinary and gastrointestinal toxicity measured at year 2 of follow-up using the Common Toxicity Criteria

Safety Issue? (FDAAA) Yes

Genitourinary and gastrointestinal toxicity measured at year 3 of follow-up using the Common Toxicity Criteria

Lawson Health Research Institute

Principal Investigator

Adenocarcinoma

Micronutrients

Vitamins

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

Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.

Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.

Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.

Undergo hypofractionated radiation therapy

Hypofractionated Radiation Therapy

Quality-of-Life Assessment

Questionnaire Administration

Carlos E. Vargas, M.D.

This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

PRIMARY OBJECTIVE:

I. To determine if stereotactic body radiation therapy (SBRT) would result in similar freedom from failure (FFF) than standard fractionation photon therapy.

EXPLORATORY OBJECTIVES:

I. After completion of radiation therapy, determine the incidence of grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events \[CTCAE\] version 4).

II. After completion of radiation therapy, determine the incidence of grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 4).

III. After completion of radiation therapy, determine the incidence of quality of life issues following completion of radiation therapy.

IV. After completion of radiation therapy, determine the incidence of impotence after the use of radiation therapy at 3 years.

V. After completion of radiation therapy, determine the incidence of freedom from biochemical failure (FFBF) at 5 years.

VI. After completion of radiation therapy, determine the incidence of clinical failure: local and/or distant at 5 years.

VII. After completion of radiation therapy, determine the incidence of salvage androgen deprivation use (SAD) at 5 years.

VIII. After completion of radiation therapy, determine the incidence of progression free survival: using clinical, biochemical and SAD as events at 5 years.

IX. After completion of radiation therapy, determine the incidence of overall survival at 5 years.

X. After completion of radiation therapy, determine the incidence of disease-specific survival at 5 years.

XI. Determine the impact of radiation therapy on quality of life. XII. Determine overall GI and GU toxicity. XIII. Determine prostate and normal structure movement during radiation therapy (RT) with the use of scans.

XIV. Correlate pathologic and radiologic findings with outcomes. XV. Correlate pre-RT prostate specific antigen (PSA) levels with outcomes. XVI. Correlate variation in proton therapy or x-ray dosimetry and outcomes. XVII. Develop a quality assurance process for prostate proton therapy. XVIII. Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity.

XIX. Allow for future research of pathologic risk factors that may influence prognosis; this information will help us to attempt to characterize their presence in prostate cancer with high risk features after prostatectomy and their potential effect on outcomes.

XX. Possibly compare dosimetric parameters of an IMRT plan with the proton therapy radiation plan.

OUTLINE: Participants are assigned to 1 of 3 groups.

GROUP I: Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.

GROUP II: Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy subcutaneously (SC) or intramuscularly (IM) for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.

GROUP III: Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.

After completion of study treatment, participants are followed up at 3 and 12 months, annually for 4 years, then every 2 years thereafter.

Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy

A Phase II Trial of Hypofractionated Radiation Therapy for Prostate Cancer With High Risk Features After Radical Prostatectomy

Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA \>= 0.5 ng/ml). Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Will be performed using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria. Descriptive measurements of frequency will be compiled. The maximum grade for each type of acute adverse events (AE) will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Similarly, grade 3 or higher GU and GI events will be estimated along with overall toxicity.

Will be performed using NCI-CTCAE version 4 criteria. The maximum grade for each type of acute adverse events (AE) will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Similarly, grade 3 or higher GU and GI events will be estimated along with overall toxicity.

Will be measured from the date of the start of treatment to the date of documented local failure as determined either by clinical exam, imaging, or by prostate rebiopsy.

Summation of relative scores for quality of life items from the Expanded Prostate Cancer Index Composite (EPIC) instrument will be used to measure each individual's quality of life. The difference in mean scores will be assessed with the t-test. To assess changes in health-related QOL from baseline, a clinically significant difference will be defined as half of a standard deviation (SD) and at least a 10-point change. Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Analysis will include percent change from baseline using t-tests and generalized linear models to test for changes at each time point and non-zero slope respectfully.

Summation of relative scores for sexual function items (items 31 through 39) from the Expanded Prostate Cancer Index Composite (EPIC) instrument will be used to measure each individual's quality of life. Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate.

Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate.

Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% confidence intervals (CIs).

Will use clinical, biochemical and SAD as events. Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs.

Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2	NCT02229734	Prostate Cancer	Radiation Androgen Suppre...	70 Years -	Lawson Health Research Institute
Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy	NCT03570827	Prostate Adenoc... Stage IIB Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros...	Androgen Suppre... Hypofractionate... Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic

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