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.
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).
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.
Single group
Drug: 68-Ga PSMA11
Drug0-3 months since initiation of ADT. Baseline PSMA PET imaging. 4-20 sites of metastasis by PSMA PET Will be injected/assessed in line with its FDA label. Other Name:
Adaptive stereotactic ablative radiotherapy (SABR)
RadiationPre-plan 5 fraction SABR 35-40 Gy. SOC systemic therapy allows for ADT and ARSI intensification. Delivery of 3 pulses to all sites. Pulses delivered weekly.
68Ga-PSMA-11
DrugRepeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected/assessed in line with its FDA label.
Adaptive stereotactive ablative radiotherapy (SABR)
RadiationDelivery of 2 additional pulses to all remaining PSMA PET visible sites
Reduction in PSMA-positive TTV
will be measured by the decrease in TTV (%) on a per-patient basis between the initial scan and post-SABR PSMA PET.
Reduction in SABR treatment intensity
Will be measured by the decrease in proportion of tumor lesions treated to initially prescribed 5 fractions (%) due specifically to complete metabolic response on interim PET PSMA after 3 fractions, as compared to initially planned lesions on a per patient basis.
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University of Texas Southwestern Medical Center
Lead sponsor
Varian, a Siemens Healthineers Company
Collaborator
Telix Pharmaceuticals (Innovations) Pty Ltd
Collaborator
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