Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer
Sponsor: Mayo Clinic + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Modified radiographic progression-free survival (mrPFS) (Groups A & B)
Time frame: Up to 5 years
Distant progression-free survival (PFS) (Groups C & D)
Time frame: Up to 5 years
Secondary Endpoints
Overall survival (OS)
Biochemcial progression-free survival (bPFS)
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Disease characteristics: * DEVIATE (Groups A and B only): * Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer * Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and/or conventional imaging * Serum testosterone \> 100ng/dL * BRIO (Gropus C \& D only): * Prostate-specific antigen (PSA) between 0.2 and 1.5 ng/mL with PSA above 0.2 on at least two consecutive measurements at least 5 days apart * No local or metastatic recurrence apparent on advanced molecular imaging * Serum testosterone \> 100 ng/dL * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 * Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration) * Platelet count ≥ 80,000/mm\^3 (obtained ≤ 15 days prior to registration) * Alanine aminotransfer…
Read full criteria on CT.gov →✦ Analyst Commentary
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