Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Oligometastatic Prostate Carcinoma | Oligometastatic Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Proton Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (moderate hypofractionation)
- description
- Patients undergo photon IMRT or PBRT 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy
- Radiation: Proton Beam Radiation Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Procedure: Biospecimen Collection
- type
- EXPERIMENTAL
- label
- Arm II (conventional fractionation)
- description
- Patients undergo IMRT or PBRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available