NL-OMON54469
Recruiting
Phase 3
SPLASH: Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using 177Lu- PNT2002 PSMA Therapy After Second-line Hormonal Treatment - SPLASH
POINT BioPharma,0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- prostate cancer
- Sponsor
- POINT BioPharma,
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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