CompletedPhase 3

Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

United States, Canada588 participantsStarted 2003-06

Plain-language summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.

Who can participate

Age range

18 Years – 120 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 * T1c-T2b, N0, M0 * Intermediate-risk disease, as defined by 1 of the following: * Gleason score \< 7 AND prostate-specific antigen (PSA) 10-20 ng/mL * Gleason score 7 AND PSA \< 10 ng/mL * No evidence of distant metastases * Prostate volume ≤ 60 cc by transrectal ultrasonography * American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Patients must use effective contraception * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site * No major medical or psychiatric illness that would preclude study therapy * No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Prior neoadjuvant hormonal therapy allowed provided the following are true: * Therapy was initiated within 2-6 months of study enrollment * Therapy was no more than 6 months in duration * Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration * No concurrent hormonal therapy Radiotherapy * No prior pelvic radiotherapy Surgery * No prior radical surgery for prostate cancer * No …

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

5-Year Freedom From Progression Rate

Timeframe: From randomization to 5 years

Trial details

NCT IDNCT00063882

SponsorRadiation Therapy Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2019-05-21

View on ClinicalTrials.gov More Prostate Cancer trials