Metastatic Prostate AdenocarcinomaPhase 2NCT04190446
A Study To Evaluate Hypofractionated Proton Therapy Or IMRT For Recurrent, Oligometastatic Prostate Cancer
A Phase 2 study testing Intensity-Modulated Radiation Therapy, Proton Beam Radiation Therapy and Quality-of-Life Assessment in people with Metastatic Prostate Adenocarcinoma and Oligometastatic Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma
- What is being tested?
- Intensity-Modulated Radiation Therapy, Proton Beam Radiation Therapy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 22 Nov 2028
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Radiotherapy With Hypofractionated Abdomino-Pelvic Salvage for Oligonodal Disease Study (RHAPSODY): MC1851 A Randomized, Parallel Phase II Trial Utilizing Proton Therapy or IMRT
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Intensity-Modulated Radiation Therapy, Proton Beam Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, Computed Tomography
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Undergo IMRT
Proton Beam Radiation TherapyRadiation
Also called PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy
Undergo proton beam radiation therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT scan
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging (MRI) Scan, Medical Imaging
Undergo MRI
Biospecimen CollectionProcedure or surgery
Also called Biospecimen Collected, Specimen Collection, Biological Sample Collection, Sample Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Late Grade 3 or Higher GI and/or GU Toxicity
Assessed by the percent 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.
Measured: 24 months
Secondary outcomes (4)
Incidence of Acute Adverse Events
Assessed by the percent 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.
Measured: 3 months
Incidence of Late Adverse Events
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.
Measured: 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.
Measured: 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.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start6 Jan 2020
- Primary completion22 Nov 2025
- Study completion22 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian J. Davis, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190446
- Sponsor's protocol ID
- MC1851
- Other IDs
- 19-000708, RHAPSODY
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2019
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy With Hypofractionated Abdomino-Pelvic Salvage for Oligonodal Disease Study (RHAPSODY): MC1851 A Randomized, Parallel Phase II Trial Utilizing Proton Therapy or IMRT
- ClinicalTrials.gov ID
- NCT04190446
- Acronym / sponsor ID
- MC1851
- Conditions
- Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 22 Nov 2028 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Posted 20 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (moderate hypofractionation) | Experimental | 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 CollectionPatients 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 | 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 CollectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated RadiotherapyUndergo IMRT | Radiation | Arm I (moderate hypofractionation), Arm II (conventional fractionation) |
| Proton Beam Radiation TherapyAlso: PBRT, Proton, Proton EBRT, Proton External Beam RadiotherapyUndergo proton beam radiation therapy | Radiation | Arm I (moderate hypofractionation), Arm II (conventional fractionation) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (moderate hypofractionation), Arm II (conventional fractionation) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (moderate hypofractionation), Arm II (conventional fractionation) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT scan | Procedure or surgery | Arm I (moderate hypofractionation), Arm II (conventional fractionation) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging (MRI) Scan, Medical ImagingUndergo MRI | Procedure or surgery | Arm I (moderate hypofractionation), Arm II (conventional fractionation) |
| Biospecimen CollectionAlso: Biospecimen Collected, Specimen Collection, Biological Sample Collection, Sample CollectionUndergo blood sample collection | Procedure or surgery | Arm I (moderate hypofractionation), Arm II (conventional fractionation) |
Primary outcome
Incidence of Late Grade 3 or Higher GI and/or GU Toxicity
Time frame: 24 months
Assessed by the percent 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.
4 secondary outcomes
Incidence of Acute Adverse Events
Time frame: 3 months
Incidence of Late Adverse Events
Time frame: 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
Time frame: Up to 60 months
Incidence of Adverse Events
Time frame: Up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Metastatic Prostate Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1/2
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Ovarian Cancer, Pancreas Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J. Davis, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensity-Modulated Radiation Therapy, Proton Beam Radiation Therapy and Quality-of-Life Assessment in people with Metastatic Prostate Adenocarcinoma and Oligometastatic Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Late Grade 3 or Higher GI and/or GU Toxicity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.