Radionuclide therapy with 177Lu-PSMA plus Abiraterone (with ADT) versus Abiraterone (with ADT) alone in metastatic, hormone-sensitive prostate cancer: a randomized phase 2 trial - REPLASE

Tata Memorial Hospital0 sites0 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\.Biopsy proven adenocarcinoma of the prostate
•2\.Metastatic disease (poly metastatic â??more than 3 metastatic lesions) evident on
•imaging (CT and/or bone scan/Ga PSMA).
•3\. Patients who are planned for treatment with Abiraterone.
•3\.PSMA\-avid disease on Ga PSMA scan (uptake equal or more than the liver)
•5\. ECOG performance status 0\-2
•5\.Participant is willing to comply with all study treatments, procedures, and assessments
•6\.Signed, written, informed consent.

•1\.ADT started more than 13 weeks prior to randomisation
•2\.Rising PSA after starting ADT for metastatic disease.
•3\.Sjogrens disease are other contraindications to Lu\-PSMA.
•4\.Oligometastatic disease â?? who have less than 3 or 3 metastatic lesions.
•5\.Other active malignancy within the last 3 years that has not been treated adequately with curative intent.
•6\.Poor renal function â?? serum creatinine \> 1\.6mg/dl or a creatinine clearance of \< 50 ml/min.
•7\.Compromised bone marrow function\-
•Hemoglobin level \< 9 g/dl
•Platelets \< 1,00,000 per cubic milliliter
•WBC count less than 2000 millilitre.

Not specified