SPLASH: Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using 177Lu-PNT2002 PSMA Therapy After Second-line Hormonal Treatment - SPLASH

Point BioPharma Inc.0 sites390 target enrollmentAugust 2, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 2, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•Patients are eligible to be included in the study only if all of the following criteria apply:
•1\. Male aged 18 years or older.
•2\. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
•3\. Ineligible or averse to chemotherapeutic treatment options.
•4\. Patients must have progressive mCRPC at the time of consent based on at least 1 of the following criteria:
•a. Serum/plasma PSA progression defined as increase in PSA greater than 25% and \>2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart.
•b. Soft\-tissue progression defined as an increase \=20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non\-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion.
•c. Progression of bone disease: defined as appearance of two or more new lesions by bone scan.
•5\. Progression on previous treatment with one ARAT (abiraterone or enzalutamide or darolutamide or apalutamide) in either the CSPC or CRPC setting.
•6\. PSMA\-PET scan (i.e., 68Ga\-PSMA\-11 or 18F\-DCFPyL) positive as determined by the sponsor's central reader.

•Patients are excluded from the study if any of the following criteria apply:
•1\. If noted in pathology report, prostate cancer with known significant (\>10% present in cells) sarcomatoid or spindle cell or neuroendocrine components. Any small cell component in the cancer should result in exclusion.
•2\. Prior treatment for prostate cancer \=28 days prior to randomization, with the exclusion of first line local external beam, ARAT, luteinizing hormone\-releasing hormone (LHRH) agonist or antagonist therapy, or non\-radioactive bone\-targeted agents.
•3\. Any prior cytotoxic chemotherapy for CRPC (e.g., cabazitaxel or docetaxel); chemotherapy for hormone\-sensitive prostate cancer (HSPC) is allowed if the last dose was administered \>1 year prior to consent.
•4\. Prior treatment with systemic radionuclides (e.g. radium\-223, rhenium\-186, strontium\-89\).
•5\. Prior immuno\-therapy, except for sipuleucel\-T.
•6\. Prior PSMA\-targeted radioligand therapy, e.g., Lu\-177\-PSMA\-617, I 131\-1095\.
•7\. Prior poly ADP ribose polymerase (PARP) inhibitor for prostate cancer.
•8\. Patients who progressed on 2 or more lines of ARATs.
•9\. Patients receiving bone\-targeted therapy (e.g. denosumab, zoledronic acid) are excluded if they are not on stable doses for at least 4 weeks prior to randomization.