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| ID | Type | Description | Link |
|---|---|---|---|
| 19-000708 | Other Identifier | Mayo Clinic Institutional Review Board | |
| RHAPSODY | Other Identifier | Mayo Clinic Radiation Oncology |
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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.
PRIMARY OBJECTIVE:
I. To assess late >= grade 3 gastrointestinal (GI) and/or genitourinary (GU) toxicity of interest within each treatment arm, moderate hypofractionation (MHF) and conventional fractionation (CF), delivered with PBRT or IMRT (late defined as 3 to 24 months after protocol radiation therapy [RT]).
SECONDARY OBJECTIVES:
I. Late grade >= 2 GI and/or GU toxicities of interest within 24 months after protocol treatment, using Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.
II. Acute grade >= 3 GI and/or GU toxicities of interest during and within 3 months after the protocol treatment, using CTCAE v4.0.
III. Compare the rates of late >= grade 3 GI and/or GU toxicity between the 2 treatment schedules.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo IMRT or PBRT 5 days a week over 3 weeks. Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), and blood sample collection throughout the study.
ARM II: 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.
After completion of study, patients are followed up at 3-6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (moderate hypofractionation) | Experimental | 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. |
|
| Arm II (conventional fractionation) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-Modulated Radiation Therapy | Radiation | Undergo IMRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of late > grade 3 GI and/or GU toxicity | Assessed by the number of patients who experience a late (≥ 90 days after RT start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE) defined as possibly, probably, or definitely related to radiation therapy (RT). Adverse events will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | Up to 24 months after RT |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute adverse events | Assessed by the number of patients with >= grade 3 GI or GU acute adverse events. Acute AEs are defined as those that occur from day 1, or commencement of RT, through 3 months after the completion of protocol treatment. | Up to 3 months after the completion of RT |
| Incidence of late adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire | The EPIC-26 questionnaire is a 26-item questionnaire used to assess health-related quality of life (HRQOL). Items are scores on a Likert-type scales such as 0-4 where 0=no problem and 4=big problem. Higher scores indicate better HRQOL. | Baseline, up to 60 months |
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
Zubrod performance score (PS) =< 1
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian J. Davis, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2026 |
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| Proton Beam Radiation Therapy | Radiation | Undergo proton beam radiation therapy |
|
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| Computed Tomography | Procedure | Undergo CT scan |
|
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
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| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
|
Assessed by the number of ≥ grade 2 GI or GU late adverse events per CTCAE v 4.0 will be recorded. A late AE is defined as an adverse event that occurs any time between 3 months and 2 years after completion of protocol treatment. |
| Between 3 months and 2 years after completion of proton beam therapy |
| Incidence of grade 3 or higher GI or GU adverse events per treatment schedule | Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates of late ≥ grade 3 GI and/or GU toxicity will be compared between the treatment schedules. | Up to 60 months |
| Incidence of adverse events | Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient. | Up to 60 months |
| Disease-free survival |
Defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause |
| Up to 60 months |
| Disease-specific mortality | Defined as the time from registration until death due to prostate cancer (death attributed to carcinoma of the prostate by the investigator or death due to complications of treatment). The distribution of disease-specific mortality will be estimated using the cumulative incidence function, with death from other causes as the competing event. | Up to 60 months |
| Overall survival | Defined as the time from registration until death due to any cause | Up to 60 months |
| Jun 2, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2022 | Jun 2, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D061766 | Proton Therapy |
| D011522 | Protons |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D063193 | Heavy Ion Radiotherapy |
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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