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
Sponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
Varian, a Siemens Healthineers Company
Collaborator
Telix Pharmaceuticals (Innovations) Pty Ltd
Collaborator