Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.

Eligibility criteria

Qualifiers

History of pathologically confirmed prostate cancer.

Age >=18 years.

Performance status ECOG 0-2.

Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within <=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).

Disqualifiers

Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.

Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.

Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.

Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.

Trial design

Treatments tested in this trial

  • Drug: 68-Ga PSMA11
  • Adaptive stereotactic ablative radiotherapy (SABR)
  • 68Ga-PSMA-11
  • Adaptive stereotactive ablative radiotherapy (SABR)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

Varian, a Siemens Healthineers Company

Collaborator

Telix Pharmaceuticals (Innovations) Pty Ltd

Collaborator