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NCT Number: NCT04190446

A Study To Evaluate Hypofractionated Proton Therapy Or IMRT For Recurrent, Oligometastatic Prostate Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Prostate Adenocarcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Oligometastatic Prostate Carcinoma Prostate Adenocarcinoma Prostatic Diseases Prostatic Neoplasms Recurrent Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensity-Modulated Radiation Therapy

Radiation

Undergo IMRT

Other names: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Proton Beam Radiation Therapy

Radiation

Undergo proton beam radiation therapy

Other names: PBRT, Proton, Proton EBRT, Proton External Beam Radiotherapy, Proton Radiation Therapy, Radiation, Proton Beam, External beam radiation therapy protons (procedure), emission tomography (procedure), positron emission tomography scan, Positron-Emission Tomography, PT

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Computed Tomography

Procedure

Undergo CT scan

Other names: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized axial tomography (procedure), Computerized Tomography (CT) scan, computerized tomography, CT, CT SCAN, tomography

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging (MRI) Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging, Structural MRI, sMRI

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biospecimen Collected, Specimen Collection, Biological Sample Collection, Sample Collection

Primary outcomes

  1. Incidence of late > grade 3 GI and/or GU toxicity

    Time frame: Up to 24 months after RT

    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.

Secondary outcomes

  1. Incidence of acute adverse events

    Time frame: Up to 3 months after the completion of RT

    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.

  2. Incidence of late adverse events

    Time frame: Between 3 months and 2 years after completion of proton beam therapy

    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.

  3. Incidence of grade 3 or higher GI or GU adverse events per treatment schedule

    Time frame: Up to 60 months

    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.

  4. Incidence of adverse events

    Time frame: Up to 60 months

    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.

Other outcomes

  1. Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire

    Time frame: Baseline, up to 60 months

    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.

  2. Disease-free survival

    Time frame: Up to 60 months

    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

  3. Disease-specific mortality

    Time frame: Up to 60 months

    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.

  4. Overall survival

    Time frame: Up to 60 months

    Defined as the time from registration until death due to any cause

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Radiotherapy With Hypofractionated Abdomino-Pelvic Salvage for Oligonodal Disease Study (RHAPSODY): MC1851 A Randomized, Parallel Phase II Trial Utilizing Proton Therapy or IMRT

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Dec 9, 2019
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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