Personalized versus fixed‑dose Lutetium‑177 PSMA therapy for metastatic castration‑resistant prostate cancer

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

Participants with PSMA‑positive metastatic castration‑resistant prostate cancer are randomized to receive either a standard fixed activity or a personalized activity of Lutetium‑177‑PSMA‑617 guided by renal dosimetry. Up to six treatment cycles are given every six weeks, with regular imaging, laboratory tests, and patient questionnaires to track safety and exposure. The trial specifically aims to see whether cumulative or per‑cycle activity can be increased in most participants under the personalized approach and to document the incidence of predefined adverse reactions. This is a Phase 1, single‑center safety and feasibility study conducted at an academic hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;
2. Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy;
3. Progressive mCRPC with rising PSA level, defined by PCWG3 criteria (sequence of two rising values above a baseline at a minimum of 1-week intervals, with serum testosterone level ≤ 1.7 nmol/dL);
4. PSA ≥2 ng/mL ;
5. Prior treatment with at least one ARPI;
6. PSMA-expressing cancer, with significant PSMA expression defined as SUVpeak in at least one lesion that is superior to SUVmean of the liver on PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL), within 45 days prior to randomization;
7. ECOG Performance status 0 to 2;
8. Calculated eGFR (by CKD-EPI formula) ≥ 45 mL/min/1.73m\^2;
9. Albumin ≥ 25 g/L;
10. Platelets ≥ 100x10\^9/L;
11. Neutrophils ≥ 1.5x10\^9/L;
12. Hemoglobin ≥ 90 g/L without transfusion in the past 4 weeks;
13. Signed, written informed consent

Exclusion Criteria:

1. PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
2. Site(s) of disease that are FDG-positive, defined as SUVpeak in at least one lesion that is superior to twice (2x) SUVmean of the liver, and PSMA-negative (as above), within 45 days prior to randomization;
3. Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (adjuvant and neoadjuvant chemotherapy does not count) towards the maximum of two regimens);
4. Prior radiopharmaceutical therapy;
5. Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per investigator's assessment;
6. Active malignancy other than prostate cancer;
7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception;
8. Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;
9. Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Where it's running

• CHU de Québec-Université Laval
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Jean-Mathieu Beauregard, MD — CHU de Québec-Université Laval
• Study coordinator: Marie-Christine Dubé, Ph.D.
• Email: marie-christine.dube@crchudequebec.ulaval.ca
• Phone: 418-525-4444

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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.