Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer

Sponsor
Hospices Civils de Lyon
Study ID
NCT06866938
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) — DRUG
    Patients will be treated with intravenous \[177Lu\]Lu-PSMA-617 (Pluvicto, Novartis). One injection every 6 weeks at the dose of 7.4 GBq (±10%)

Study Details

Prostate cancer is the third leading cause of cancer-related death in men in the United States and Europe. The treatment of metastatic castration-resistant prostate cancer (mCRPC) has evolved with the arrival of the radioligand \[177Lu\]Lu-PSMA-617, which specifically targets PSMA-expressing cancer cells. The randomized phase III VISION study showed that \[177Lu\]Lu-PSMA-617 significantly improved progression-free survival and overall survival with an acceptable toxicity profile. The ReaLuP study will evaluate the efficacy of a re-treatment of \[177Lu\]Lu-PSMA-617 in patients with progressive PSMA-positive mCRPC and who have been previously treated with \[177Lu\]Lu-PSMA without evidence of progression during this first course of treatment. Patients will be treated until disease progression, unacceptable toxicity or death, or alternatively up to 9 months after the last dose of treatment. At the end of this follow up period, patients will enter the " long term follow up ", at least for 2 years after the end of the last active follow-up.

Key Dates

First listed
Mar 10, 2025
Start date
Apr 11, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2030

Study Design

Enrollment
58 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: [177Lu]Lu-PSMA-617
    Patients with metastatic castration resistance prostate cancer will be treated with intravenous \[177Lu\]Lu-PSMA-617 (Pluvicto, Novartis) at the dose of 7.4 GBq (±10%) every 6 weeks Treatment duration: 4 to 6 cycles (24 to 36 weeks)

Primary Outcome Measure

Progression-Free Survival rate [ Time Frame: At 24 weeks after the start of study treatment ]

Central Contacts

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