Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617

Part of paid clinical trials in Houston, Texas.

Sponsor
Ebrahim S Delpassand
Study ID
NCT06972628
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Administering Lutetium-177-PSMA-617 (PLUVICTO) — DRUG
    The study begins with a first cohort of three participants, each receiving a dose of 100 millicuries (mCi). After administration, participants are monitored for any dose-limiting toxicities (DLTs) during a predefined observation window. If fewer than two participants experience a DLT in a given cohort, the dose will be escalated for the next group. The dose escalation schedule is structured as follows: the second cohort receives 130 mCi (a 30% increase), the third cohort receives 162.5 mCi (a 25% increase), and the fourth cohort receives 200 mCi, a dose that is already FDA-approved and clinically accepted for mCRPC. This stepwise escalation continues until the 200 mCi dose is reached, or until two or more DLTs are observed in any cohort. If that occurs, escalation stops immediately, and the maximum tolerated dose is considered to be the previous lower dose. This becomes the optimal tolerated dose (OTD). After identifying the OTD, additional participants will be enrolled for treatment.

Study Details

The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan. Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap. The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose. The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population. This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.

Key Dates

Start date
May 23, 2025
Status verified
May 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm

Primary Outcome Measure

Radiographic progression-free survival [ Time Frame: From date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Excel Diagnostics & Nuclear Oncology CenterHoustonTexas77042
Susan Cork Therapy Coordinator
[email protected]
713-781-6200
Nereyda Sauceda, Therapy Coordinator
[email protected]
713-781-6200
Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD.Nuclear Medicine (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Excel Diagnostics & Nuclear Oncology Center· Houston, TX

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