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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

Any current or prior evidence of castration-resistant prostate cancer, defined as two consecutive rises in serum PSA, obtained at a minimum of 1-week interval, with the final PSA value >/= 1 ng/ml, while having a total testosterone < 50 ng/dl).

Adequately treated non-melanomatous skin cancer;

Adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission; or

Any other cancer from which the patient has been disease free for three years.

Trial design

Treatments tested in this trial

  • PET-directed Local Therapy using Surgery
  • PET-directed Local Therapy using Radiation
  • Salvage Local Therapy for locally recurrent disease
  • Goserelin, Histrelin, Leuprolide & Triptorelin
  • ADT + Nilutamide, Flutamide, & Bicalutamide
  • Degarelix & Relugolix
  • ADT + Docetaxel +/- prednisone
  • ADT + Abiraterone + Prednisone
  • ADT + Abiraterone + Methylprednisolone
  • ADT + Apalutamide
  • ADT + Enzalutamide
  • Prostate-directed Radiation for De novo oligometastatic prostate cancer

Treatment groups

464 Participants
are divided into 2 treatment groups