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Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration

Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration, followed by restoration of physiologic testosterone

stereotactic ablative radiotherapy

PSMA targeted radiopharmaceutical therapy

topical testosterone

Nicholas G Nickols, MD PhD

Matthew B Rettig, MD

Nicholas Nickols, MD

Nicholas George Nickols, MD PhD

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.

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).

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

Phase II Trial of Targeted Radiation With no Castration for Mcrpc

6-month radiographic progression-free survival (rPFS) measured by conventional imaging from date of initiation of PSMA radiopharmaceutical therapy

Physician reported Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

EPIC-26 contains 26 items in 5 domains (Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal). Raw scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.

This is the rate of PSA response (PSA decrease by 30%, 50%, 90%), and maximal response

Time to PSA progression per PCWG3 criteria, from date of initiation of PSMA radiopharmaceutical therapy

Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) from date of initiation of PSMA radiopharmaceutical therapy

Time-to-event, Bone progression by Prostate Cancer Working Group 3 (PCWG3) criteria and/or soft tissue progression by RECIST v1.1, from date of initiation of PSMA radiopharmaceutical therapy

Measured using Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE)

Time-to-event, a composite between time to PSA progression (PCWG3) and/or radiographic progression (PCWG3 for bone, RECIST 1.1 for soft tissue), from date of initiation of PSMA radiopharmaceutical therapy

Time-to-event, from date of initiation of PSMA radiopharmaceutical therapy

FACT-P includes a general functional status scale (consisting of four subscales: physical wellbeing, social and family wellbeing, emotional wellbeing, and functional wellbeing) and a prostate-cancer-specific subscale. Total score is calculated with general function and prostate-cancer-specific scores, and ranges from 0 to 156 (higher scores indicate better functional status).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	NCT06084338	Prostate Cancer	stereotactic ab... Pluvicto topical testost...	18 Years -	VA Office of Research and Development
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	NCT06084338	Prostate Cancer	stereotactic ab... Pluvicto topical testost...	18 Years -	VA Office of Research and Development
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	NCT06084338	Prostate Cancer	stereotactic ab... Pluvicto topical testost...	18 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for pluvicto

Every month we try and update this database with for pluvicto cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pluvicto

Every month we try and update this database with for pluvicto cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pluvicto cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.