Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery
University of Texas Southwestern Medical Center
Summary
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.
Description
This study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging. All participants will undergo standard of care systemic therapy, including ADT and androgen receptor signaling inhibitors intensification as clinically indicated, for up to three months before protocol radiotherapy. The treating radiation oncologist will pre-plan SABR to a total of 35-40 Gy in 5 fractions. The study will consist of initially delivering three qWeekly SABR "pulses" to all identified metastatic sites. The initial pulse should start within 60 (+/-30 d…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. History of pathologically confirmed prostate cancer. 2. Age \>=18 years. 3. Performance status ECOG 0-2. 4. 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). 5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR. 6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study e…
Interventions
- DrugDrug: 68-Ga PSMA11
0-3 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:
- RadiationAdaptive stereotactic ablative radiotherapy (SABR)
Pre-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.
- Drug68Ga-PSMA-11
Repeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected/assessed in line with its FDA label.
- RadiationAdaptive stereotactive ablative radiotherapy (SABR)
Delivery of 2 additional pulses to all remaining PSMA PET visible sites
Location
- University of Texas Southwestern Medical CenterDallas, Texas