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Clinical Trial · NCT07674771
Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery
Overview
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.
Sponsor
University of Texas Southwestern Medical Center
Phase
Early Phase 1
Contacts
SARAH NEUFELD, MS, MBA (CONTACT)
sarah.hardee@utsouthwestern.edu
214 645 8525
DANIEL YANG, MD (CONTACT)
daniel.yang@utsouthwestern.edu
214 645 8525
DANIEL YANG, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT07674771Drug / Compound
PSMA-11
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
Eligibility
Inclusion
- Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).
- 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).
- History of pathologically confirmed prostate cancer.
Exclusion
- 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.
- Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.
- Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.
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