Clinical Trial · NCT06574880

STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

Overview

The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.

Sponsor

Case Comprehensive Cancer Center

Phase

Phase 1/2

Contacts

Angela Y Jia, MD, PhD (CONTACT)

angela.jia@uhhospitals.org

216-844-3262

Angela Y Jia, MD, PhD (PRINCIPAL_INVESTIGATOR)

Daniel E Spratt, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT06574880

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

ECOG performance status ≤ 1
Histologic confirmation of prostate adenocarcinoma of the prostate
PSMA PET/CT must be obtained within 4 months.
PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10.

Exclusion

Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).
Prior head and neck radiation therapy.
Prostate gland size \>90 cc measured by CT, ultrasound, or MRI
* Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation. Negative PSMA PET/CT is an acceptable substitute to conventional staging.
Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.