Treatment for advanced prostate cancer using Pluvicto

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: scork@exceldiagnostics.com
• Phone: 713-781-6200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.