Active — Not RecruitingPhase 3

Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

United States, Canada, Hong Kong692 participantsStarted 2018-02-01

Plain-language summary

This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Stereotactic body radiation therapy may work better 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.

Inclusion Criteria: * Previously untreated (no local therapy such as surgery, radiation cryotherapy, high-intensity focused ultrasound \[HIFU\], etc.) localized adenocarcinoma of the prostate with the following clinical findings: * Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland); (American Joint Committee on Cancer \[AJCC\], version 7) or cT1a-c or 2a or 2b * Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP) * The patient must meet one of the following 3 criteria: 1) Gleason score must be Gleason 7(3+4) with a PSA \< 20 ng/mL, or 2) Gleason 6 (3+3) with a PSA \> 10 ng/mL and \< 20 ng/mL which is considered intermediate risk and eligible for the study (AJCC, version 7), or 3) Group Grade 1 with a PSA \> 10 ng/mL and \< 20 ng/mL or 2 with a PSA \< 20 ng/mL * If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment, the baseline PSA value may be double the initial value and the medication should be discontinued but a washout period is not required; to be eligible, a PSA drawn while still on the medicine must be: * \< 10 ng/mL if Gleason 7(3+4) (note this patient would be on stratification level 1 if PSA \< 5 ng/mL and stratification level 2 if less than 10 ng/mL) * \> 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) (note this patient would be on stratification level 3) * The prostate volume must be \< 70 cc as reported at time of biopsy or …

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

Incidence of patients-reported gastrointestinal and genitourinary toxicity

Timeframe: Up to 2 years

Disease free survival

Timeframe: Time to biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause, assessed up to 2 years

Trial details

NCT IDNCT03367702

SponsorNRG Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Stage II Prostate Adenocarcinoma AJCC v7 trials