RECRUITING

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

Conditions

Metastatic Castration-Resistant Prostate Cancer Prostate Cancer Patients With Bone Metastasis Prostate Cancer (CRPC)Prostate Cancer Prostate Cancer Metastatic Metastatic Castration-Resistant Prostate Cancer (mCRPC)super scan bone scan

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-23

Study Completion:2029-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06972628

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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).	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.

Inclusion Criteria

Exclusion 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.
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).

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.

Contacts and Locations

Study Contact

Susan Cork Therapy Coordinator

CONTACT

713-781-6200

scork@exceldiagnostics.com

Nereyda Sauceda, Therapy Coordinator

CONTACT

713-781-6200

nsauceda@exceldiagnostics.com

Principal Investigator

Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine

PRINCIPAL_INVESTIGATOR

Excel Diagnostics & Nuclear Oncology Center

Study Locations (Sites)

Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, 77042

United States

Collaborators and Investigators

Sponsor: Ebrahim S Delpassand

Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine, PRINCIPAL_INVESTIGATOR, Excel Diagnostics & Nuclear Oncology Center

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 Registration Dates

Study Start Date2025-05-23

Study Completion Date2029-04-01

Study Record Updates

Study Start Date2025-05-23

Study Completion Date2029-04-01

Terms related to this study

Keywords Provided by Researchers

Metastatic Castration-Resistant Prostate Cancer (mCRPC)
super scan bone scan
Prostate Cancer patients with bone metastasis
prostate cancer (CRPC)
Prostate cancer
Prostate cancer metastatic

Additional Relevant MeSH Terms

Metastatic Castration-Resistant Prostate Cancer
Prostate Cancer Patients With Bone Metastasis
Prostate Cancer (CRPC)
Prostate Cancer
Prostate Cancer Metastatic