NCT06972628RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 23 May 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Ebrahim S Delpassand
- Diseases
- Prostate cancer
- NCT number
- NCT06972628
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 23 May 2025 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior PSMA-targeted radioligand therapy.
- Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
- Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- Major surgery within 30 days prior to enrollment.
Other illness
- Known hypersensitivity to PLUVICTO or its components.
- History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
- 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.
Lab values
- Renal impairment (estimated glomerular filtration rate \<60 mL/min), hemoglobin \<9 g/dL, ANC \<1.5 × 10⁹/L, or platelets \< 90 × 10⁹/L.
Other
- Symptomatic or impending spinal cord compression.
- Plans to conceive or father a child during treatment and up to six months post-treatment.
Who the study is looking for
- Ability to understand and sign an informed consent form (ICF).
- Willingness and ability to comply with study requirements.
- Age ≥18 years.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Hemoglobin ≥9.0 g/dL.
- Platelet count ≥90 × 10⁹/L.
- 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).
- Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN).
- Histological, pathological, or cytological confirmation of prostate cancer.
- Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion.
- Castrate-level serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
- Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Excel Diagnostics & Nuclear Oncology Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.