Health TrialsbyHealthPanel

A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

ConditionsCancerProstate CancerMetastatic CancerMetastatic Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

>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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

500 Participants
are divided into 5 treatment groups
Group A: Cohort AExperimental treatment 2 interventions
Group B: Cohort BExperimental treatment 2 interventions
Group C: Cohort CExperimental treatment 2 interventions
Group D: Cohort DExperimental treatment 2 interventions
Group E: Cohort EExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHU de Quebec-Universite Laval

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: