A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Sponsor
CHU de Quebec-Universite Laval
Study ID
NCT05896371
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • 177Lu-PSMA-I&T - escalating renal absorbed dose — DRUG
    Personalized 177Lu-PSMA-I\&T injected activity
  • 177Lu-PSMA-I&T - recommended phase 2 regime — DRUG
    Personalized 177Lu-PSMA-I\&T injected activity

Study Details

The goal of this clinical trial is to study a personalized regime of lutetium-177 (177Lu) prostate-specific membrane antigen (PSMA) radiopharmaceutical therapy (RPT) in patients with progressive and/or symptomatic, inoperable PSMA-expressing cancers of prostatic or other origins. The main questions it aims to answer are: * To establish a dosimetry-based, personalized regime of 177Lu-PSMA * To report on the efficacy of personalized 177Lu-PSMA Participants (stratified by risk factors of toxicity) will receive up to 6 cycles of a personalized activity of 177Lu-PSMA based on renal dosimetry. In the phase 1, the prescribed absorbed dose to the kidney will be escalated, to determine the regime that will be administered in the phase 2. The best response within 12 months after the first cycle will be assessed. Salvage treatment of 3 cycles may be offered to responders after re-progression.

Key Dates

First listed
Jun 9, 2023
Start date
Mar 31, 2028
Status verified
Mar 2025
Primary completion
Mar 31, 2033
Completion
Mar 31, 2034

Study Design

Enrollment
500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Lower risk of toxicity (no risk factor)
  • Experimental: Cohort B
    Extensive bone metastasis
  • Experimental: Cohort C
    Decreased bone marrow reserve
  • Experimental: Cohort D
    Renal function impairment
  • Experimental: Cohort E
    Higher risk of toxicity (more than one risk factor and others)

Primary Outcome Measure

Phase 1: Number of dose-limiting toxicities (DLTs) [ Time Frame: 12 weeks ]

Central Contacts

Find similar trials

Nationwide
Prostate cancer trialsOncology trialsProstate oncology trialsMen's health trialsUrology trials

Related Studies