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

May 12, 2025 updated by: Ebrahim S Delpassand

177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical study investigates the safety and effectiveness of the FDA-approved drug Pluvicto (Lu-177-PSMA617).

It focuses on a unique group of patients with metastatic castration-resistant prostate cancer (mCRPC) who present with a "super scan" on bone scintigraphy-a pattern indicating widespread cancer in the bones.

These patients were excluded from prior trials like the VISION study, leaving a critical gap in clinical understanding.

The trial aims to identify the optimal safe dose of Pluvicto using a modified 3+3 dose-escalation method, beginning at a low dose that increases, and eventually reaching up to 200 mCi.

Participants will receive a total of six doses, spaced every 6 ± 1 weeks. Primary objectives include determining the maximum tolerated dose and monitoring safety using CTCAE version 5.0 criteria.

Efficacy will be evaluated through PSA level reductions based on PCWG3 guidelines.

Secondary endpoints include quality of life, radiologic response (RECIST v1.1), and overall survival.

Exploratory endpoints involve PSMA PET/CT imaging to measure treatment response through SUVmean and lesion changes.

The study includes up to 30 participants and will include expanded enrollment once the optimal dose is determined.

Routine lab tests (CBC, CMP, PSA, testosterone) and patient-reported side effects will be monitored throughout the study.

Long-term follow-up for survival and safety will continue every six months for up to five years.

Imaging (CT/MRI, bone scans, and optional PET/CT) will be performed at baseline, mid-treatment, end of treatment, and every three months post-treatment.

A complete or partial response, stable disease, or progression will be defined using both RECIST and PCWG3 guidelines.

Monthly PSA checks will continue for up to 24 months or until disease progression.

PLUVICTO is administered via IV infusion over 2-5 minutes during each session. Participants may discontinue due to progression, intolerable side effects, non-compliance, or other clinical decisions.

This study is essential in determining how to safely extend Pluvicto therapy to a previously unstudied and high-risk patient group.

Its results may expand access to this radioligand therapy and guide future treatment decisions in prostate cancer care.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77042
        • Recruiting
        • Excel Diagnostics & Nuclear Oncology Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD.Nuclear Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ability to understand and sign an informed consent form (ICF).
  2. Willingness and ability to comply with study requirements.
  3. Age ≥18 years.
  4. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  6. Hemoglobin ≥9.0 g/dL.
  7. Platelet count ≥90 × 10⁹/L.

  8. White blood cell count ≥2.0 × 10⁹/L, absolute neutrophil count (ANC) >1.5 × 10⁹/L.

    o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).

  9. Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN).
  10. Histological, pathological, or cytological confirmation of prostate cancer.
  11. Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
  12. Castrate-level serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
  13. Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).

Exclusion Criteria:

  1. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.
  2. Prior PSMA-targeted radioligand therapy.
  3. Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
  4. Known hypersensitivity to PLUVICTO or its components.
  5. Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  6. Renal impairment (estimated glomerular filtration rate <60 mL/min), hemoglobin <9 g/dL, ANC <1.5 × 10⁹/L, or platelets < 90 × 10⁹/L.
  7. History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
  8. Symptomatic or impending spinal cord compression.
  9. Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.
  10. Major surgery within 30 days prior to enrollment.
  11. Plans to conceive or father a child during treatment and up to six months post-treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Drug: Administering Lutetium-177-PSMA-617 (PLUVICTO)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
rPFS: Defined as the time from enrollment to radiographic disease progression, based on Prostate Cancer Working Group 3 (PCWG3) Guidelines (Scher et al., 2016), or death from any cause.
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.
Overall Survival
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 24 months.
OS: Defined as the time from enrollment to death from any cause.
From date of enrollment until the date of death from any cause, assessed up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ebrahim S Delpassand

Investigators

  • Principal Investigator: Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine, Excel Diagnostics & Nuclear Oncology Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 23, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

May 12, 2025

First Posted (Actual)

May 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Super-Lu-177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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