NCT04190446Active, not recruitingPhase 2
A Study To Evaluate Hypofractionated Proton Therapy Or IMRT For Recurrent, Oligometastatic Prostate Cancer
Radiotherapy With Hypofractionated Abdomino-Pelvic Salvage for Oligonodal Disease Study (RHAPSODY): MC1851 A Randomized, Parallel Phase II Trial Utilizing Proton Therapy or IMRT
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 5 Dec 2019
- Start date
- 6 Jan 2020
- Primary completion date
- 22 Nov 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT04190446
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 84
- From 6 Jan 2020 to the primary completion date, 22 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bone or visceral metastases present at the time of treatment (consolidative radiotherapy allowed)
- 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
Other illness
- Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)
- Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
Other
- Lymph node metastases beyond the pelvis and/or retroperitoneum
- Contraindications to androgen suppression
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.