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MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 13 of 16 entries
    • Site contacts updated at 1 of 3 sites
  2. Minor Study sites: 2 to 3v14
  3. Minor Re-verified, no change to tracked fieldsv13
  4. Minor Collaborators: 1 to 2v12
  5. Notable Primary and study completion dates: Apr 1, 2028 to Dec 1, 2028v11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Site details revised at 1 of 2 sitesv10
  2. Minor Study sites: 1 to 2v9
  3. Minor Eligibility criteria expanded, about 5 wordsv8
  4. Notable Primary and study completion dates: Jul 1, 2026 to Apr 1, 2028v7
  5. Minor Eligibility criteria expanded, about 20 wordsv6
  6. Minor Eligibility criteria expanded, about 16 wordsv5
  7. Notable Start date: May 24, 2024 to Jul 1, 2024v4
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2024 to May 24, 2024
    • Site details revised
    v3
  9. Notable Start date: Apr 1, 2024 to Oct 1, 2024v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to find out if giving radiation therapy (RT) to areas of metastatic prostate cancer at the time a participant is diagnosed will help control disease better than the usual treatment. This treatment is called metastasis-directed radiotherapy (MDRT). The usual treatment for prostate cancer that has spread to other parts of the body is to give lifelong treatment with hormone therapy (also known as androgen deprivation therapy or ADT). Participants may also be given prostate RT even if the disease is metastatic. Participants will receive hormone therapy (the standard treatment for prostate cancer) for 12 months. The hormone therapy agents may be taken by mouth or given as an injection. Participants will also have prostate RT. Up to 50 participants will have surgery to remove the prostate instead of having prostate RT. A portion of the participants will be randomized to receive MDRT to areas where the cancer has spread. For participants who have surgery to remove their prostate, they will be asked to allow tissue samples collected during the surgery to be sent to an outside lab for research tests and extra blood samples drawn for research tests before starting the study, and at the time the cancer becomes worse if applicable. Participation in the study will last approximately 12 months, and will be followed by their doctor for up to five years per standard of care. The main goal is to compare the efficacy of the standard of care (standard systemic therapy + definitive prostate-directed local therapy) versus the standard of care with metastasis-directed radiotherapy (MDRT) for consolidation of metastatic disease.
Trial Details
NCT Number NCT06150417
Lead Sponsor Case Comprehensive Cancer Center
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions
(from sponsor)
Prostate Cancer, Malignant Neoplasm of Prostate, Secondary Malignant Neoplasm of Prostate
Related terms Prostatic Neoplasms
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov