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| Name | Class |
|---|---|
| CHU de Quebec-Universite Laval | OTHER |
| Novartis | INDUSTRY |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in a population of patients with metastatic castrate-resistant prostate cancer (mCRPC). The main questions it aims to answer are:
Researchers will compare participants receiving a personalized regime to participants receiving the standard fixed-activity regime of 177Lu-PSMA-617 to see if the activity can be safely increased through personalization based on renal dosimetry (i.e. the measure of how much radiation is actually delivered to the kidney).
Participants will receive up to 6 treatments of 177Lu-PSMA-617 every 6 weeks and be regularly evaluated with imaging and laboratory tests, as well as with questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized activity | Experimental |
| |
| Fixed activity | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-PSMA-617 | Drug | 6 cycles of personalized activity (1st cycle based on BSA and eGFR; cycles 2-6 based on renal dosimetry), maximum 22.2 GBq, every 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Administered activity of 177Lu-PSMA-617 | In GBq, cumulative and average per cycle. | From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles) |
| Number of participants with subacute adverse events of special interest (AESIs) | Subacute AESIs are:
| From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Best biochemical response | Maximum percent decrease of serum prostate-specific antigen (PSA) after first administration. | From first administration until 52 weeks or the start of another anti-cancer treatment or death, whichever is earliest |
| PSA progression-free survival (PSA-PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Christine Dubé, Ph.D. | Contact | 418-525-4444 | marie-christine.dube@crchudequebec.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Mathieu Beauregard, MD | CHU de Québec-Université Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Québec-Université Laval | Recruiting | Québec | Quebec | G1R2J6 | Canada |
There is an intent to create an imaging and data bank from this study.
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| ID | Term |
|---|---|
| C000610110 | Pluvicto |
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| 177Lu-PSMA-617 | Drug | 6 cycles of 7.4 GBq every 6 weeks |
|
Time from first administration to an increase in PSA greater than 25%, and greater than 2 ng/ml, above nadir, confirmed at least 3 weeks later. |
| From date of first administration until the date of PSA progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months |
| Best radiological response rates | Percentage of participants achieving each RECIST 1.1 response category as their best response: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), overall response (i.e., CR or PR; a.k.a. overall response rate, ORR), disease control (i.e CR, PR or SD; a.k.a. disease control rate, DCR). | From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles) |
| Radiological progression-free survival (rPFS) | Time from first administration to the date of radiographic disease progression based on RECIST 1.1/PCWG3. | From date of first administration until the date of radiological progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months |
| Investigator-assessed overall PFS | Time from first administration to the earliest of clinical (worsening of a patient's clinical status attributed to disease progression), biochemical or radiological progression considering all data (scheduled and unscheduled) available to the investigator. | From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months |
| Time to first symptomatic skeletal event (SSE) | Time to first Symptomatic Skeletal Event (SSE) is defined as the time from first administration to the date of the SSE. The SSE date is the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. | From date of first administration until the date of first SSE or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months |
| Overall survival (OS) | Overall Survival (OS) is defined as the time from the date of the first administration to the date of death due to any cause. | From date of first administration until the date of death, assessed over a minimum of 60 months |
| Metabolic response on FDG-PET/CT | Metabolic response is defined as complete metabolic response (CMR, disappearance of all lesions on FDG PET), partial metabolic response (PMR, decrease of uptake by ≥30%), stable metabolic disease (SMD, variation of FDG uptake by <30%), progressive metabolic disease (PMD, increase of FDG uptake by ≥30%) | At baseline and at 12 weeks |
| Molecular response on PSMA-PET/CT | Molecular response is defined as the variation of molecular tumor volume (MTV) on PSMA-PET/CT | At baseline and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles) |
| Best molecular response on quantitative 177Lu SPECT/CT during treatment | Best molecular response is defined as the maximum percent decrease of molecular tumor volume (MTV) at any time after post-treatment quantitative 177Lu SPECT/CT performed on the first cycle's Day 3, up to the post-treatment quantitative 177Lu SPECT/CT performed on the last cycle's Day 3 | From first cycle's Day 3 until the last cycle's Day 3 (each cycle is 6 weeks, up to 6 consecutive cycles) |
| Number of participants with any adverse events (AEs) | All adverse events that occur from the first administration of 177Lu-PSMA-617 until 6 weeks after the last administration of 177Lu-PSMA-617 or prior to the initiation of subsequent anticancer treatment. | From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles) |
| Number of participants with laboratory adverse events (AEs) | Adverse events seen on laboratory (hematology, biochemistry) that occur from the first administration of 177Lu-PSMA-617 until progression or until the initiation of subsequent anticancer treatment if earlier. | From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months |
| Number of participants with delayed adverse events of special interest (AESIs) | Delayed AESIs (renal impairment and secondary hematological malignancies) that occur from the first administration of 177Lu-PSMA-617 until death (or study termination) | From date of first administration until the date of death, assessed over a minimum of 60 months |
| Variation of score on EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire at baseline | At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles) |
| Variation of score on Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire at baseline | At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles) |
| Variation of score on Brief Pain Inventory (BPI-SF) questionnaire at baseline | At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles) |
| Variation of score on Multidisciplinary Salivary Gland Society (MSGS) questionnaire at baseline | At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles) |