Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

Study acronym: VA STARPORT
StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Record History

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  1. Enrollment closed, study ongoing Show 7 more changesShow less
    • Final enrollment: 378 participants (planned 464)
    • Primary completion date changed from estimate of Sep 30, 2026 to Oct 2, 2026
    • Interventions: ADT + Abiraterone + Methylprednisolone (Drug), ADT + Abiraterone + Prednisone (Drug), ADT + Apalutamide (Drug), ADT + Docetaxel +/… to ADT + Abiraterone + Methylprednisolone (Drug), ADT + Abiraterone + Prednisone (Drug), ADT + Apalutamide (Drug), ADT + Docetaxel +/…
    • Eligibility criteria expanded, about 91 words
    • Secondary endpoints: details revised at 3 of 10 entries
    • Study description revised
    • Site details revised at 20 of 20 sites
  2. Primary completion date: Mar 31, 2026 to Sep 30, 2026
    • Site contacts updated at 1 of 20 sites
    v20
  3. Site details revised at 2 of 20 sitesv19
  4. Study sites: 19 to 20v18
  5. Primary completion date: Jul 1, 2025 to Mar 31, 2026
    • Study completion date: Dec 1, 2025 to Mar 30, 2029
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Site details revised at 2 of 19 sitesv16
  2. Site details revised at 2 of 19 sitesv15
  3. Site details revised at 1 of 19 sitesv14
  4. Study sites: 18 to 19
    • Eligibility criteria expanded, about 2 words
    v13
  5. Interventions: ADT + Abiraterone + Methylprednisolone (Drug), ADT + Abiraterone + Prednisone (Drug), ADT + Apalutamide (Drug), ADT + Docetaxel +/… to ADT + Abiraterone + Methylprednisolone (Drug), ADT + Abiraterone + Prednisone (Drug), ADT + Apalutamide (Drug), ADT + Docetaxel +/…
    • Eligibility criteria shortened, about 34 words
    • Study description shortened, about 17 words
    • Study title revised
    v12
  6. Re-verified, no change to tracked fieldsv11
  7. Study sites: 16 to 18v10
  8. Re-verified, no change to tracked fieldsv9
  9. Site details revised at 1 of 16 sitesv8
  10. Eligibility criteria expanded, about 51 wordsv7
  11. Interventions: ADT + Abiraterone + Methylprednisolone (Drug), ADT + Abiraterone + Prednisone (Drug), ADT + Apalutamide (Drug), ADT + Docetaxel +/… to ADT + Abiraterone + Methylprednisolone (Drug), ADT + Abiraterone + Prednisone (Drug), ADT + Apalutamide (Drug), ADT + Docetaxel +/…
    • Eligibility criteria expanded, about 125 words
    • Study sites revised (16)
    v6
  12. Site details revised at 3 of 16 sites
    • Eligibility criteria shortened, about 1 word
    v5
  13. Site details revised at 10 of 16 sitesv4
  14. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 16 of 16 sites
    v3
  15. Primary completion date: Jun 2, 2025 to Jul 1, 2025
    • Start date: Jun 2, 2021 to Jul 1, 2021
    • Site contacts updated at 1 of 16 sites
    v2
  1. Study First Submitted
  • 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.
This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.
Trial Details
NCT Number NCT04787744
Lead Sponsor VA Office of Research and Development
Conditions
(from sponsor)		 Prostate Cancer, Oligometastasis, Oligorecurrence, Recurrent Prostate Cancer, Metastatic Prostate Cancer, De Novo Prostate Cancer
Related terms Neoplasm Metastasis, Prostatic Neoplasms
Enrollment 378 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov