A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer

NCT04190446 | Active Not Recruiting Phase 2 FDA Device

• 3 other identifiers: MC1851NCI-2019-0770519-000708
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or 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 proton beam radiation therapy 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

Metastatic Prostate Adenocarcinoma; Oligometastatic Prostate Carcinoma; Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Incidence of acute adverse events

  Up to 3 months after the completion of RT

• Incidence of late adverse events

  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

  Up to 60 months

• Incidence of adverse events Incidence of adverse events Incidence of adverse events

  Up to 60 months

Other Outcomes (4)

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

  Baseline, up to 60 months

• Disease-free survival

  Up to 60 months

• Disease-specific survival

  Up to 60 months

Study Arms (2)

Arm I (proton beam radiation therapy)

EXPERIMENTAL

Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

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 (IMRT)

EXPERIMENTAL

Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

Radiation: Intensity-Modulated Radiation Therapy; Other: Questionnaire Administration; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Interventions

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Arm II (IMRT)

Proton Beam Radiation Therapy RADIATION

Undergo proton beam radiation therapy

Also known as: 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, proton magnetic resonance spectroscopic imaging, PT

Arm I (proton beam radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (proton beam radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm I (proton beam radiation therapy); Arm II (IMRT)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT SCAN, tomography

Arm I (proton beam radiation therapy); Arm II (IMRT)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

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

Arm I (proton beam radiation therapy); Arm II (IMRT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (proton beam radiation therapy); Arm II (IMRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 splenic vessels \[SVs\] 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

You may not qualify if:

• Bone or visceral metastases present
• Lymph node metastases beyond the pelvis and/or retroperitoneum
• Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)
• Contraindications to androgen suppression
• Concurrent antineoplastic agents (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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Proton Therapy; Protons; Magnetic Resonance Spectroscopy; X-Rays; Specimen Handling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Heavy Ion Radiotherapy; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Radiation; Radiation, Ionizing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Brian J. Davis, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: January 6, 2020
• Primary Completion: November 22, 2025
• Study Completion (Estimated): November 22, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)