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A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

PROstate-specific Membrane Antigen DosImetry-Guided EndoradiotherapY: a Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy (PRODIGY-1)

NCT05896371•CHU de Quebec-Universite Laval

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\>18 y.o. adults able to provide consent
•Inoperable or metastatic PSMA-expressing cancer, with significant PSMA expression defined as uptake in at least one lesion that is superior to that of the liver on PSMA positron-emission tomography (PET) within 3 months prior to enrolment
•Cancer progression documented within 3 months prior to enrolment as per the investigator's assessment, without initiation of another anti-cancer treatment since (excluding palliative radiation therapy to a minority of the tumor burden), unless that anti-cancer treatment was stopped prematurely because of intolerance
•For participants with a cancer other than mCRPC, a recommendation from a multidisciplinary tumor board (MDT) in favor of PSMA RPT must be obtained

Exclusion Criteria

•Platelets \< 50 x 106/L
•Absolute neutrophil count (ANC) \< 1.0 x 106/L
•Eastern Cooperative Oncology Group (ECOG) 4 or prognosis \< 3 months, for cancer-related or other serious medical conditions, as per investigator's assessment
•Known presence of central nervous system metastasis at risk of complication, which cannot be adequately stabilized (e.g. radiotherapy or corticoid prophylaxis), as per investigator's assessment
•Any condition that would limit the ability to comply with the study protocol, as per investigator's assessment
•Pregnancy or breastfeeding (e.g. for female participants with non-prostate cancer)

Key Dates

Start Date

March 1, 2028

Primary Completion Date

March 1, 2033

Completion Date

March 1, 2034

Last Updated

March 30, 2025

Enrollment

500

ESTIMATED participants

Conditions

CancerProstate CancerMetastatic CancerMetastatic Prostate Cancer

Interventions

177Lu-PSMA-I&T - escalating renal absorbed dose

DRUG

177Lu-PSMA-I&T - recommended phase 2 regime

DRUG

Contacts

Guillaume Bouvet, Ph.D.

CONTACT

418-525-4444 guillaume.bouvet@crchudequebec.ulaval.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Inclusion Criteria

Exclusion Criteria

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