Flexible dosing of 177Lu-PSMA-617 for advanced prostate cancer treatment

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 effectiveness of a flexible dosing schedule of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously undergone chemotherapy and androgen receptor-targeted therapy. The study aims to determine if extending treatment cycles beyond the standard six can improve survival rates and quality of life while assessing safety and disease control. Participants will be randomized to receive either the flexible dosing schedule or the standard fixed schedule, with the potential for treatment holidays for those showing good responses. The trial will also explore the dosimetry of the treatment in organs and tumor lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have prostate cancer proven by histopathology
* Patients must have ≥ 1 metastatic lesion by any imaging (CT, magnetic resonance imaging \[MRI\], bone scan, PET)
* Patients must have received at least one regimen of chemotherapy for mCRPC
* Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)
* Patients must be eligible by PSMA PET VISION criteria. PSMA PET/CT must be performed within 8 weeks of planned first cycle of 177Lu-PSMA-617
* White blood cell (WBC) ≥ 2,500/ul
* Platelets (PLT) ≥ 100,000/ul
* Hemoglobin (Hb) ≥ 9.0 g/dl
* Absolute neutrophil count (ANC) ≥ 1,500 ul
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patients must be adults ≥ 18 years of age
* Patients must have the ability to understand and sign an approved informed consent form (ICF)
* Patients must have the ability to understand and comply with all protocol requirements

Exclusion Criteria:

* Prior cycle of 177Lu-PSMA-617 therapy
* Less than 6 weeks between last myelosuppressive therapy (including docetaxel, cabazitaxel, strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, hemi-body irradiation) and first cycle of 177Lu-PSMA-617 therapy
* Glomerular filtration rate (GFR) \< 50 ml/min
* Urinary tract obstruction or marked hydronephrosis

Where it's running

• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Jeremie Calais — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Stephanie Lira
• Email: StephanieLira@mednet.ucla.edu
• Phone: 310-206-0596

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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.