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Hormone Therapy
Androgen-Deprivation + Radiation Therapy for Prostate Cancer
Phase 3
Waitlist Available
Led By Mack Roach, MD
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Zubrod performance status 0-1
No acquired immune deficiency syndrome (AIDS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date when baseline epic-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy.
Awards & highlights
Study Summary
This trial is studying androgen-deprivation therapy and radiation therapy to see how well they work in treating patients with prostate cancer.
Who is the study for?
Men with moderate to high-risk prostate cancer, confirmed by biopsy within the last 180 days. They should have a PSA level under 50 ng/mL and no bone metastases. Men previously on active surveillance for low risk prostate cancer who now have higher risk disease may also join if re-biopsied within 180 days. No prior pelvic radiation or radical prostate surgery is allowed, and they must be willing to use contraception.Check my eligibility
What is being tested?
This phase III trial is testing whether combining androgen-deprivation therapy (which lowers male hormones) with whole-pelvic radiotherapy (a type of radiation that targets the entire pelvic area) is effective in treating patients with prostate cancer compared to other treatments.See study design
What are the potential side effects?
Possible side effects include hot flashes, reduced sexual desire, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea, skin irritation in treated areas, and potential long-term impacts on heart health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my usual activities without help.
Select...
I do not have AIDS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date when baseline epic-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date when baseline epic-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
Assessment and comparison of Quality Adjusted Life Years (QALYs)
Biochemical failure by the Phoenix definition (PSA ≥ 2 ng/mL over the nadir PSA)
Cause-specific survival
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment1 Intervention
Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.
Group II: Arm IActive Control1 Intervention
Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)* or 3D-conformal radiation therapy (3D-CRT)* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,930,561 Total Patients Enrolled
560 Trials studying Prostate Cancer
504,581 Patients Enrolled for Prostate Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
98,260 Total Patients Enrolled
19 Trials studying Prostate Cancer
9,709 Patients Enrolled for Prostate Cancer
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
62,335 Total Patients Enrolled
32 Trials studying Prostate Cancer
17,999 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with prostate cancer at moderate to high risk of coming back within the last 6 months.I am not willing or able to use birth control.I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.My prostate cancer has a Gleason score of 7-10, is in early stages, and my PSA is under 50 ng/mL.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I have had hormone therapy for prostate cancer.I have AIDS.My prostate cancer is intermediate or high risk, with a recent biopsy confirming this.I've had a recent exam of my prostate, bones, and abdomen.I have had blood cancer before.I have had major surgery for prostate cancer.I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.I have received hormone therapy for prostate cancer within the last 45 days.I have not taken Finasteride in the last 30 days.I have not taken Dutasteride or Jalyn in the last 90 days.I have received chemotherapy for prostate cancer.I have had radiation therapy on the cancer area being studied.My recent scans show no signs of cancer in my lymph nodes.My recent scans show no bone metastases.I can carry out all my usual activities without help.I do not have AIDS.I have received hormone therapy for prostate cancer.My prostate cancer has a Gleason score of 6, is advanced but not widespread, and my PSA is under 50.My recent scans showed no signs of cancer in my lymph nodes.Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.I have not had any other cancer besides this one in the last 3 years.I have had major surgery or cryosurgery for prostate cancer.I had cancer within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II
- Group 2: Arm I
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being accepted into the trial at this time?
"This clinical trial, which was posted on July 1st 2011 and updated most recently on April 6th 2022 is not seeking new patients at this time. However, there are many other trials (1364 in total) that are currently recruiting individuals."
Answered by AI
In how many different settings is this research being conducted?
"There are 100 sites running this study, some of which include NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center in New york, UW Cancer Center Johnson Creek in Johnson Creek, and McLaren Cancer Institute-Lapeer Region in Lapeer."
Answered by AI
How does WPRT compare to other cancer treatments in terms of patient safety?
"While there is some data supporting the efficacy of Whole-pelvic radiotherapy (WPRT), as this is a Phase 3 trial, multiple rounds of clinical data support its safety. Consequently, our team has given it a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
How old are they?
18 - 65
What site did they apply to?
Saint Francis Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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