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Gepersonaliseerd versus vaste activiteit 177LU-PSMA-617 Radiopharmaceutical Therapy (Prodigy-2) (PRODIGY-2)

9 november 2026 bijgewerkt door: Jean-Mathieu Beauregard

Prostaatspecifieke membraanantigeen dosimetrie-geleide endoradiotherapie: een gerandomiseerde, enkelblinde, pilotstudie van gepersonaliseerde versus vaste activiteit 177LU-PSMA-617 radiofarmaceutische therapie (PreDigy-2)

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:

  1. Can the administered activity (cumulative or per-cycle) be increased in a majority of participants?
  2. What is the incidence of some specific adverse reactions during the treatment?

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1R2J6

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria:

  1. Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;
  2. Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy (serum testosterone level ≤ 1.7 nmol/dL within 60 days from first cycle);
  3. Biochemically progressive mCRPC with rising PSA level, defined by PCWG3 criteria (sequence of two rising values above a baseline at a minimum of 1-week intervals, with the second of these within 60 days from first cycle);
  4. PSA ≥2 ng/mL ;
  5. Prior treatment with at least one ARPI;
  6. PSMA-expressing cancer, with significant PSMA expression defined as SUVpeak in at least one lesion that is superior to SUVmean of the liver on PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL), within 45 days prior to randomization;
  7. ECOG Performance status 0 to 2;
  8. Calculated eGFR (by CKD-EPI formula) ≥ 45 mL/min/1.73m^2;
  9. Albumin ≥ 25 g/L;
  10. Platelets ≥ 100x10^9/L;
  11. Neutrophils ≥ 1.5x10^9/L;
  12. Hemoglobin ≥ 90 g/L without transfusion in the past 4 weeks;
  13. Signed, written informed consent

Exclusion Criteria:

  1. PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
  2. Site(s) of disease that are FDG-positive, defined as SUVpeak in at least one lesion that is superior to twice (2x) SUVmean of the liver, and PSMA-negative (as above), within 45 days prior to randomization;
  3. Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (a line is counted if at least 2 cycles were administered; adjuvant and neoadjuvant chemotherapy does not count towards the maximum of two lines);
  4. Prior PSMA-directed radiopharmaceutical therapy (radium-223 is allowed);
  5. Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per investigator's assessment;
  6. Active malignancy other than prostate cancer;
  7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception;
  8. Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;
  9. Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Gepersonaliseerde activiteit
Geneesmiddel: 177Lu-PSMA-617

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

Geneesmiddel: 177Lu-PSMA-617

6 cycles of 7.4 GBq every 6 weeks
Actieve vergelijker: Vaste activiteit
Geneesmiddel: 177Lu-PSMA-617

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

Geneesmiddel: 177Lu-PSMA-617

6 cycles of 7.4 GBq every 6 weeks

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Administered activity of 177Lu-PSMA-617
Tijdsspanne: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)

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)
Tijdsspanne: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)

Subacute AESIs are:

  • treatment-related grade 3-4 thrombopenia persisting more than 12 weeks
  • treatment-related grade 3-4 neutropenia persisting more than 12 weeks
  • treatment-related creatinine elevation to >2x baseline and >ULN (upper limit of normal) persisting more than 12 weeks
  • treatment-related grade 4 febrile neutropenia
  • treatment-related grade 4 non-hematological toxicity
  • treatment-related death
From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Variatie van score op de vragenlijst van de Euroqol-5 Dimension-5-niveau (EQ-5D-5L) bij aanvang
Tijdsspanne: Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Variatie van score op functionele beoordeling van kankertherapie - prostaat (fact -p) vragenlijst bij aanvang
Tijdsspanne: Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Variatie van score op korte pijninventaris (BPI-SF) vragenlijst bij aanvang
Tijdsspanne: Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Variatie van score op de multidisciplinaire speekselkliervereniging (MSGS) vragenlijst bij aanvang
Tijdsspanne: Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Bij aanvang, na 18 weken, en aan het einde van de behandeling (elke cyclus is 6 weken, tot 6 opeenvolgende cycli)
Best biochemical response
Tijdsspanne: From first administration until 52 weeks or the start of another anti-cancer treatment or death, whichever is earliest

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)
Tijdsspanne: 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

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
Radiological progression-free survival (rPFS)
Tijdsspanne: 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

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
Tijdsspanne: 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 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)
Tijdsspanne: 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

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)
Tijdsspanne: From date of first administration until the date of death, assessed over a minimum of 60 months

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
Tijdsspanne: At baseline and at 12 weeks

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
Tijdsspanne: At baseline and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles)

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
Tijdsspanne: From first cycle's Day 3 until the last cycle's Day 3 (each cycle is 6 weeks, up to 6 consecutive cycles)

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)
Tijdsspanne: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)

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)
Tijdsspanne: 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

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)
Tijdsspanne: From date of first administration until the date of death, assessed over a minimum of 60 months

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jean-Mathieu Beauregard

Medewerkers

Novartis
Canadian Institutes of Health Research (CIHR)
CHU de Quebec-Universite Laval

Onderzoekers

  • Hoofdonderzoeker: Jean-Mathieu Beauregard, MD, CHU de Québec-Université Laval

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 augustus 2025

Primaire voltooiing (Geschat)

1 maart 2029

Studie voltooiing (Geschat)

1 maart 2033

Studieregistratiedata

Eerst ingediend

25 maart 2025

Eerst ingediend dat voldeed aan de QC-criteria

22 april 2025

Eerst geplaatst (Werkelijk)

24 april 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

9 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-7829

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

There is an intent to create an imaging and data bank from this study.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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