Spots Global Cancer Trial Database for Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

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Trial Identification

Brief Title: Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Official Title: Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Study ID: NCT06084338

Conditions

Prostate Cancer

Interventions

stereotactic ablative radiotherapy

Pluvicto

topical testosterone

Study Description

Brief Summary: This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.

Detailed Description: This is a randomized, parallel-arm, two-stage open-label phase 2 study of comprehensive metastasis directed therapy in the form of stereotactic body radiation therapy (SBRT) to all detectable sites of disease plus PSMA targeted radiopharmaceutical therapy (pluvicto), discontinuation of castration, with and without testosterone replacement therapy (TRT) in metastatic castration resistant prostate cancer (mCRPC).