TerminatedPhase 2

MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer

Stopped: Loss of required MRI resources needed to conduct protocol-specified procedures

United States6 participantsStarted 2022-11-16

Plain-language summary

This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.

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: * Age: above 18 years * Participants must be histologically proven, adenocarcinoma prostate * Localized to the prostate without positive pelvic lymph node involvement * No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan * High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) \> 20 ng/mL * Ability to receive long term hormone therapy * Karnofsky performance score (KPS) \> 70 * No prior history of therapeutic irradiation to pelvis * Patient willing and reliable for follow-up and quality of life (QOL) * English speaking/reading Exclusion Criteria: * Evidence of distant or pelvic metastasis at any time since presentation * Life expectancy \< 2 years * Previous radiation therapy (RT) to prostate or prostatectomy * A previous trans-urethral resection of the prostate (TURP) * Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT * Patients with known obstructive symptoms with stricture * Any contraindication to radiotherapy such as inflammatory bowel disease

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

Rate of late grade 2+ genitourinary (GU) toxicity

Timeframe: At 1 year

Trial details

NCT IDNCT05676463

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-07

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