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Trial Title:
A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy
NCT ID:
NCT05896371
Condition:
Cancer
Prostate Cancer
Metastatic Cancer
Metastatic Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate-Specific Membrane Antigen
177Lu-PSMA
Radiopharmaceutical Therapy
Dosimetry
Personalized
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-PSMA-I&T - escalating renal absorbed dose
Description:
Personalized 177Lu-PSMA-I&T injected activity
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Arm group label:
Cohort E
Intervention type:
Drug
Intervention name:
177Lu-PSMA-I&T - recommended phase 2 regime
Description:
Personalized 177Lu-PSMA-I&T injected activity
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Arm group label:
Cohort E
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2025
Completion date:
June 15, 2032
Lead sponsor:
Agency:
CHU de Quebec-Universite Laval
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (CIHR)
Agency class:
Other
Source:
CHU de Quebec-Universite Laval
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05896371
