CompletedPhase 2

Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate

United States91 participantsStarted 2008-12-22

Plain-language summary

This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.

Who can participate

Age range

18 Years – 100 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: * Histologically confirmed, locally confined adenocarcinoma of the prostate * Clinical stages T1a to T2b PSA of less than 10 ng per ml * Gleason score of less than 3+4=7 * The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer * Signed study-specific consent form prior to registration Exclusion Criteria: * Stage T3 to 4 disease * Gleason 4+3=7 or higher score * PSA greater than 10 ng per ml * Clinical or Pathological Lymph node involvement N1 * Evidence of distant metastases M1 * Radical surgery for carcinoma of the prostate * Previous Chemotherapy or pelvic radiation therapy * Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years * History of inflammatory bowel disease * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up

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

Number of Participants With Grade 2 or Greater GU and GI Toxicity

Timeframe: Up to 5 years

Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS

Timeframe: Baseline, 12 -, 24 -, and 36-month follow-up

The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)

Timeframe: Baseline, 12 months, 24 months, and 36-month follow-up

EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)

Timeframe: Baseline, 12 months, 24 months, and 36-month follow-up

Trial details

NCT IDNCT00809991

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-24

Results submitted2026-01-06

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 100 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.

What they're measuring

Number of Participants With Grade 2 or Greater GU and GI Toxicity

Timeframe: Up to 5 years

Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS

Timeframe: Baseline, 12 -, 24 -, and 36-month follow-up

The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)

Timeframe: Baseline, 12 months, 24 months, and 36-month follow-up

EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions)

Timeframe: Baseline, 12 months, 24 months, and 36-month follow-up