CompletedPhase 3

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

United States, Canada1,534 participantsStarted 2002-03

Plain-language summary

RATIONALE: Specialized 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. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II 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: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1b-T2b * Meets one of the following criteria: * Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but \< 20 ng/mL * Gleason score 7 AND PSA \< 15 ng/mL * No regional lymph node involvement * No distant metastases PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer * No other major medical or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy: * At least 3 months since prior finasteride * No other prior hormonal therapy, including: * Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) * Antiandrogens (e.g., flutamide or bicalutamide) * Estrogens (e.g., diethylstilbestrol) * No concurrent (neoadjuvant or adjuvant) hormonal therapy Radiotherapy: * No prior pelvic irradiation or brachytherapy Surgery: * No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer * No prior surgical castration (bilateral orchiectomy) Other: * At least 3 months since prior finaster…

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

Overall Survival

Timeframe: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.

Trial details

NCT IDNCT00033631

SponsorRadiation Therapy Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2016-12-16

View on ClinicalTrials.gov More Prostate Cancer trials