A Study To Evaluate Hypofractionated Proton Therapy Or IMRT For Recurrent, Oligometastatic Prosta… (NCT04190446) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study To Evaluate Hypofractionated Proton Therapy Or IMRT For Recurrent, Oligometastatic Prostate Cancer
United States84 participantsStarted 2020-01-06
Plain-language summary
This phase II trial studies the side effects of radiation therapy \[hypofractionated proton beam radiation therapy (PBRT) or intensity-modulated radiation therapy (IMRT)\] for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated PBRT delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent 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:
* Male; age \>= 18 years
* Histological confirmation of prostate adenocarcinoma
* Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate \[can also include treatment of seminal vesicles (SVs) and lymph nodes (LNs)\] or salvage RT to the prostate fossa (can also include prior pelvic RT)
* Oligometastatic extent of disease
* Recurrent disease involving lymph nodes as diagnosed with choline positron emission tomography (PET)/computed tomography (CT) or other advanced PET imaging \[prostate-specific membrane antigen (PSMA) or flucyclovine\]
* Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes
* Zubrod performance score (PS) =\< 1
* Signed informed consent
Exclusion Criteria:
* Bone or visceral metastases present at the time of treatment (consolidative radiotherapy allowed)
* Lymph node metastases beyond the pelvis and/or retroperitoneum
* Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)
* Contraindications to androgen suppression
* Concurrent cytotoxic chemotherapy
* Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer
* Inability to start the radiation portion of the protocol treatment within 6 months after study enrollment
* Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or 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.