A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Prostate Cancer Clinical Trial

— PRODIGY-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05896371
• Other study ID #: 2023-6822
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 29, 2024
• Est. completion date: June 15, 2032

Study information

• Verified date: November 2023
• Source: CHU de Quebec-Universite Laval
• Contact: Guillaume Bouvet, Ph.D.
• Phone: 418-525-4444
• Email: guillaume.bouvet[@]crchudequebec.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 15, 2032
• Est. primary completion date: June 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Metastatic Cancer
• Metastatic Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 177Lu-PSMA-I&T - escalating renal absorbed dose
Personalized 177Lu-PSMA-I&T injected activity
• 177Lu-PSMA-I&T - recommended phase 2 regime
Personalized 177Lu-PSMA-I&T injected activity

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Number of dose-limiting toxicities (DLTs)		12 weeks
Primary	Phase 2: Overall response rate (ORR)		Up to 12 months
Primary	Phase 2: Biochemical response rate (PSA50)		Up to 12 months
Secondary	Frequency and grades of treatment-related adverse events (AEs)		Up to 12 months
Secondary	Delayed AEs of particular interest		Up to 5 years
Secondary	Phase 1: Overall response rate (ORR)		Up to 12 months
Secondary	Phase 1: Biochemical response rate (PSA50)		Up to 12 months
Secondary	Quality of life patient-reported outcome measures (PROMs) response rates		Up to 12 months
Secondary	Progression-free survival (PFS)		Up to 5 years
Secondary	Overall survival (OS)		Up to 5 years