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NCT Number: NCT05896371

A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

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.

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Key information

Conditions

Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Cancer Metastatic Prostate Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Phase 1: Number of dose-limiting toxicities (DLTs)

    Time frame: 12 weeks

  2. Phase 2: Overall response rate (ORR)

    Time frame: Up to 12 months

  3. Phase 2: Biochemical response rate (PSA50)

    Time frame: Up to 12 months

Secondary outcomes

  1. Frequency and grades of treatment-related adverse events (AEs)

    Time frame: Up to 12 months

  2. Delayed AEs of particular interest

    Time frame: Up to 5 years

  3. Phase 1: Overall response rate (ORR)

    Time frame: Up to 12 months

  4. Phase 1: Biochemical response rate (PSA50)

    Time frame: Up to 12 months

  5. Quality of life patient-reported outcome measures (PROMs) response rates

    Time frame: Up to 12 months

  6. Progression-free survival (PFS)

    Time frame: Up to 5 years

  7. Overall survival (OS)

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Bouvet, Ph.D.

CONTACT

[email protected]

418-525-4444

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: PRODIGY-1

Important dates

Study start
2028
Primary completion
2033
Study completion
2034
First posted
Jun 9, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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