Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer (NCT01368588) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
United States, Canada, Hong Kong2,590 participantsStarted 2011-07
Plain-language summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:
* Gleason score 7-10 + T1c-T2b (palpation) + PSA \< 50 ng/ml (includes intermediate and high risk patients);
* Gleason score 6 + T2c-T4 (palpation) + PSA \< 50 ng/ml
-ORGleason score 6 + ≥ 50% (positive) biopsies + PSA \< 50 ng/ml;
* Gleason score 6 + T1c-T2b (palpation) + PSA \> 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
* History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
* Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration.
* Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
\*No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute).
* Equivocal bone scan findings are allowed if …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Alive (Overall Survival)
Timeframe: From randomization to death or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.