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

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Results posted: Oct 20, 2026 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints revised (4)
    • Study description revised
  2. Re-verified, no change to tracked fieldsv21
  3. Eligibility criteria revised
    • Secondary endpoints revised (4)
    • Study description expanded, about 1 word
    v20
  4. Eligibility criteria expanded, about 7 wordsv19
  5. 2 versions Re-verified since Nov 25, 2025, no change to tracked fieldsv17-v18
Show 15 earlier versionsHide 15 earlier versions
  1. Study completion date: Nov 22, 2025 to Nov 22, 2028v16
  2. Primary endpoint revised
    • Secondary endpoints revised (4)
    v15
  3. Primary and study completion dates: Dec 31, 2024 to Nov 22, 2025
    • Study title shortened, about 6 words
    v14
  4. Interventions: Intensity-Modulated Radiation Therapy (Radiation), Proton Beam Radiation Therapy (Radiation), Quality-of-Life Assessment (Other)… to Biospecimen Collection (Procedure), Computed Tomography (Procedure), Intensity-Modulated Radiation Therapy (Radiation), Magnetic Resonance…v13
  5. Study description expanded, about 36 wordsv12
  6. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 83 to confirmed 84
    • Site details revised
    v11
  7. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    • Collaborators shortened, about 4 words
    v10
  8. Re-verified, no change to tracked fieldsv9
  9. Trial status: Suspended to Active, Not Recruitingv8
  10. Trial status: Recruiting to Suspended Sponsor's reason: per study
    • Site details revised
    v7
  11. Eligibility criteria expanded, about 9 words
    • Site contact updated
    v6
  12. Study site revised
    • Study description shortened, about 1 word
    v5
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 30, 2020 to Jan 6, 2020
    • Site details revised
    v4
  14. Start date: Jan 30, 2020 to Apr 30, 2020v3
  15. Start date: Dec 4, 2019 to Jan 30, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
1,027 trials monitored
See 130 trials at risk
Prostate Cancer
2,562 trials monitored
See 170 trials at risk
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.
Trial Details
NCT Number NCT04190446
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov