This phase I/II trial studies the side effects and best dose of 177Lu-PSMA-617 when given together with stereotactic body radiation therapy (SBRT) and to see how well it works in treating patients with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced). Radioactive drugs, such as 177Lu-PSMA-617, may carry radiation directly to tumor cells and not harm normal cells. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving 177Lu-PSMA-617 with SBRT may work better in treating patients with locally advanced prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06574880.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Angela Y Jia
Phone: 216-844-3262
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) when combined with prostate and nodal SBRT treatment. (Phase I)
II. To determine the 3-year androgen deprivation therapy (ADT)-free survival following treatment with 177Lu-PSMA617 and prostate and nodal SBRT. (Phase II)
SECONDARY OBJECTIVES:
I. Overall survival (OS), radiographic progression-free survival (rPFS), time-to-castration-resistant prostate cancer, and prostate-specific cancer mortality (PCSM).
II. To determine the rate of obtaining a post-treatment prostate specific antigen (PSA) of ≤ 0.5 ng/mL following treatment with 177Lu-PSMA-617 and prostate and nodal SBRT. For patients with a baseline PSA of ≤ 0.5 ng/mL, which would be exceedingly rare, we will determine the rate of obtaining a post-treatment PSA of ≤ 0.1 ng/mL following with 177Lu-PSMA-617 and prostate and nodal SBRT.
III. To describe acute and late treatment toxicity following treatment with 177LuPSMA-617 and prostate and nodal SBRT.
IV. To describe post treatment patient reported quality of life following treatment with 177Lu-PSMA-617 and prostate and nodal SBRT (Expanded Prostate Cancer Index Composite-26 [EPIC-26], Xerostomia-related Quality of Life Questionnaire [XQ], Functional Assessment of Cancer Therapy-Radionuclide Therapy [FACT-RNT]).
V. To determine biochemical recurrence (BCR), defined as PSA nadir + 2 ng/mL.
VI. To determine time-to-next-intervention (TTNI), the cumulative incidence of distant metastases (DM), and prostate cancer-specific survival (PCSM) following treatment with 177Lu-PSMA-617 and prostate and nodal SBRT.
CORRELATIVE OBJECTIVES:
I. To correlate deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and circulating biomarkers with oncologic endpoints of response to treatment.
II. To define tumor absorbed dose after 177Lu-PSMA-617 treatment.
III. To identify imaging features to develop a predictive biomarker of which patients benefit most from 177Lu-PSMA-617.
OUTLINE: This is a phase I, dose-escalation study of 177Lu-PSMA-617 in combination with SBRT followed by a phase II study.
Patients receive 177Lu-PSMA-617 intravenously (IV) on day 1 cycle 1. Patients then undergo prostate and nodal SBRT on non-consecutive days for 5 doses starting on day 43 in the absence of disease progression or unacceptable toxicity. Six weeks following completion of SBRT, patients receive 177Lu-PSMA-617 IV on day 1 cycle 2. Cycles repeat every 6 weeks for up to 1 additional cycle in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) and blood sample collection throughout the study as well as single photon emission computed tomography (SPECT) on study. Patients may also undergo magnetic resonance imaging (MRI) and biopsy throughout the study.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months for year 1, every 4-6 months for year 2, and every 6 months for years 3-5.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorAngela Y Jia