A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy (PRODIGY-1)

November 20, 2023 updated by: CHU de Quebec-Universite Laval

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Lower risk of toxicity (no risk factor)
Drug: 177Lu-PSMA-I&T - escalating renal absorbed dose
Personalized 177Lu-PSMA-I&T injected activity
Drug: 177Lu-PSMA-I&T - recommended phase 2 regime
Personalized 177Lu-PSMA-I&T injected activity
Experimental: Cohort B
Extensive bone metastasis
Drug: 177Lu-PSMA-I&T - escalating renal absorbed dose
Personalized 177Lu-PSMA-I&T injected activity
Drug: 177Lu-PSMA-I&T - recommended phase 2 regime
Personalized 177Lu-PSMA-I&T injected activity
Experimental: Cohort C
Decreased bone marrow reserve
Drug: 177Lu-PSMA-I&T - escalating renal absorbed dose
Personalized 177Lu-PSMA-I&T injected activity
Drug: 177Lu-PSMA-I&T - recommended phase 2 regime
Personalized 177Lu-PSMA-I&T injected activity
Experimental: Cohort D
Renal function impairment
Drug: 177Lu-PSMA-I&T - escalating renal absorbed dose
Personalized 177Lu-PSMA-I&T injected activity
Drug: 177Lu-PSMA-I&T - recommended phase 2 regime
Personalized 177Lu-PSMA-I&T injected activity
Experimental: Cohort E
Higher risk of toxicity (more than one risk factor and others)
Drug: 177Lu-PSMA-I&T - escalating renal absorbed dose
Personalized 177Lu-PSMA-I&T injected activity
Drug: 177Lu-PSMA-I&T - recommended phase 2 regime
Personalized 177Lu-PSMA-I&T injected activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase 1: Number of dose-limiting toxicities (DLTs)
Time Frame: 12 weeks
12 weeks
Phase 2: Overall response rate (ORR)
Time Frame: Up to 12 months
Up to 12 months
Phase 2: Biochemical response rate (PSA50)
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 5 years
Up to 5 years
Progression-free survival (PFS)
Time Frame: Up to 5 years
Up to 5 years
Frequency and grades of treatment-related adverse events (AEs)
Time Frame: Up to 12 months
Up to 12 months
Delayed AEs of particular interest
Time Frame: Up to 5 years
Up to 5 years
Phase 1: Overall response rate (ORR)
Time Frame: Up to 12 months
Up to 12 months
Phase 1: Biochemical response rate (PSA50)
Time Frame: Up to 12 months
Up to 12 months
Quality of life patient-reported outcome measures (PROMs) response rates
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Jean-Mathieu Beauregard, MD,MSc,FRCPC, CHU de Québec - Université Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 29, 2024

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2032

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-6822

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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