177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT06329830
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177Lu-PSMA-617 — DRUG
    7.4 GBq (200 mCi) via IV infusion once every 6 weeks for 6 cycles
  • Niraparib abiraterone acetate — DRUG
    Dual action drug tablet that is taken orally by the participant once per day in one of the following dose combinations depending on the cohort assignment and number of dose-limiting toxicities: 200 mg/1000 mg, 150 mg/1000 mg, 100 mg/1000 mg, 50 mg/500 mg
  • Prednisone — DRUG
    5 mg orally twice per day

Study Details

The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor.

Key Dates

Start date
Oct 31, 2024
Status verified
Sep 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 177Lu-PSMA-617 in Combination with Niraparib/Abiraterone Acetate plus Prednisone
    177Lu-PSMA-617 will be administered per standard of care at 7.4 gigabecquerel (GBq) (200 mCi) via intravenous (IV) infusion once every cycle (6 weeks) for 6 cycles. Niraparib/Abiraterone Acetate (Nira/AA) will be taken orally by the participant daily until disease progression or unacceptable toxicity. The starting dose level is 150 mg/1000 mg Nira/AA. Other dose levels include 200 mg/1000 mg, 100 mg/1000 mg, or 50 mg/500 mg Nira/AA once daily. Prednisone (5 mg) will be taken orally by the participant twice daily each day that Nira/AA is taken.

Primary Outcome Measure

Determination of the recommended phase 2 dose (RP2D) [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer InstituteMiamiFlorida33176-

Find similar trials in Miami, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Miami Cancer Institute· Miami, FL

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