Treatment for advanced prostate cancer using Pluvicto

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

This study is testing if a new treatment called Pluvicto can help men with advanced prostate cancer that has spread to their bones feel better and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Excel Diagnostics and Nuclear Oncology Center (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06972628 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of Lutetium-177-PSMA-617 (Pluvicto) in men with metastatic castration-resistant prostate cancer (mCRPC) who have extensive bone metastases indicated by a 'super scan' pattern on bone scans. The study aims to identify the optimal dosing regimen for this specific patient population, which was previously excluded from other trials. Participants will receive a total of six doses of Pluvicto, with monitoring for safety and efficacy through various clinical endpoints, including PSA level reductions and quality of life assessments. The trial will also explore long-term outcomes and treatment responses through imaging techniques.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with metastatic castration-resistant prostate cancer and a super scan pattern on bone scans.

Not a fit: Patients without skeletal metastases or those who do not meet the specific hematologic and renal criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have been excluded from previous studies.

How similar studies have performed: While Pluvicto has been FDA-approved, this specific approach for patients with super scan findings is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Houston, Texas

• Excel Diagnostics & Nuclear Oncology Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine — Excel Diagnostics & Nuclear Oncology Center
• Study coordinator: Susan Cork Therapy Coordinator

Conditions Metastatic Castration-Resistant Prostate Cancer; Prostate Cancer Patients With Bone Metastasis; Prostate Cancer; Prostate Cancer Metastatic; super scan bone scan; Prostate Cancer patients with bone metastasis; prostate cancer; Prostate cancer