Castration-Resistant Prostate Carcinoma Clinical Trial
Official title:
Minority-Inclusive Imaging Biomarker-Based End of Therapy Trial for 177Lu-PSMA-617, a Randomized De-Escalation Theranostic Trial for Metastatic Castrate Resistant Prostate Cancer
This phase IV studies how to improve the use of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen [PSMA]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) utilizing a treatment pause after 5 cycles versus standard continuous 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.
PRIMARY OBJECTIVES: To determine whether progression-free survival (PFS) is non-inferior among patients randomized to treatment pause versus standard treatment in patients with metastatic castrate resistant prostate cancer (mCRPC) who have minimal residual disease on post-therapy single photon emission computed tomography (SPECT) after 5 cycles of 177Lu-PSMA-617 treatment. SECONDARY OBJECTIVES: I. To assess time to subsequent treatment (TTST) in this patient population for each randomized arm. II. To assess time to progression (TTP) between randomized arms in this patient population for each randomized arm. III. To assess overall survival (OS) in this patient population for each randomized arm. IV. To compare toxicities in treatment pause versus standard treatment in this patient population. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive 177Lu-PSMA-617 intravenously (IV) over 10-15 minutes on day 1 of each cycle. Cycles repeat every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-prostate specific membrane antigen-11 (gallium Ga 68-labeled PSMA-11) IV and undergo positron emission tomography (PET)/computed tomography (CT) and a bone scan during screening and on the trial. Patients also undergo SPECT/CT and blood sample collection on the trial. ARM II: Patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each cycle. Cycles repeat every 42 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo clinical observation until documented first progression. Patients may resume treatment with 77Lu-PSMA-617. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo PET/CT and a bone scan during screening and on the trial. Patients also undergo SPECT/CT and blood sample collection on the trial. After completion of study treatment, patients who achieved complete response, partial response, or stable disease are followed up at 3 months, then every 3 months for 1 year, and then every 6 months for up to 3 years from time of registration. ;
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