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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years, 24 months
  • Procedures mentioned: MRI scans, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

TX