Spersonalizowana vs. stała aktywność 177LU-PSMA-617 Terapia radiofarmaceutyczna (Prodigy-2) (PRODIGY-2)
Endoradioterapia z przewodnikiem z kierowanym antygenem specyficznym dla prosty prostaty: randomizowane, kontrolowane, pilotażowe badanie spersonalizowanej i stałej aktywności 177LU-PSMA-617 Terapia radiofarmaceutyczna (Prodigy-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:
- Can the administered activity (cumulative or per-cycle) be increased in a majority of participants?
- 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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Marie-Christine Dubé, Ph.D.
- Numer telefonu: 418-525-4444
- E-mail: marie-christine.dube@crchudequebec.ulaval.ca
Lokalizacje studiów
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Quebec
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Québec, Quebec, Kanada, G1R2J6
- Rekrutacyjny
- CHU de Québec-Université Laval
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Kontakt:
- Marie-Christine Dubé, Ph.D.
- Numer telefonu: 418-525-4444
- E-mail: marie-christine.dube@crchudequebec.ulaval.ca
-
Główny śledczy:
- Jean-Mathieu Beauregard, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;
- 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);
- 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);
- PSA ≥2 ng/mL ;
- Prior treatment with at least one ARPI;
- 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;
- ECOG Performance status 0 to 2;
- Calculated eGFR (by CKD-EPI formula) ≥ 45 mL/min/1.73m^2;
- Albumin ≥ 25 g/L;
- Platelets ≥ 100x10^9/L;
- Neutrophils ≥ 1.5x10^9/L;
- Hemoglobin ≥ 90 g/L without transfusion in the past 4 weeks;
- Signed, written informed consent
Exclusion Criteria:
- PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
- 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;
- 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);
- Prior PSMA-directed radiopharmaceutical therapy (radium-223 is allowed);
- 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;
- Active malignancy other than prostate cancer;
- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception;
- Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;
- Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Spersonalizowana aktywność
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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 6 cycles of 7.4 GBq every 6 weeks |
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Aktywny komparator: Ustalona aktywność
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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 6 cycles of 7.4 GBq every 6 weeks |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Administered activity of 177Lu-PSMA-617
Ramy czasowe: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
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In GBq, cumulative and average per cycle. |
From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
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Number of participants with subacute adverse events of special interest (AESIs)
Ramy czasowe: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
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Subacute AESIs are:
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From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Zmienność wyniku na poziomie euroqol-5 wymiaru-5 (EQ-5D-5L) na podstawie podstawowej
Ramy czasowe: Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
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Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
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Zmienność oceny funkcjonalnej terapii przeciwnowotworowej - Kwestionariusz prostaty (FACT -P) na początku
Ramy czasowe: Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
|
Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
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Zmienność wyniku w kwestionariuszu krótkiego zapasu bólu (BPI-SF) na początku
Ramy czasowe: Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
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Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
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Zmienność wyniku w kwestionariuszu Multidyscyplinarnego Kwestionariusza Towarzystwa Śliniaka (MSGS) na początku
Ramy czasowe: Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
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Na początku, po 18 tygodniach i pod koniec leczenia (każdy cykl ma 6 tygodni, do 6 kolejnych cykli)
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Best biochemical response
Ramy czasowe: From first administration until 52 weeks or the start of another anti-cancer treatment or death, whichever is earliest
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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
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PSA progression-free survival (PSA-PFS)
Ramy czasowe: 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
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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
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Radiological progression-free survival (rPFS)
Ramy czasowe: 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
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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
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Investigator-assessed overall PFS
Ramy czasowe: 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
|
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Time to first symptomatic skeletal event (SSE)
Ramy czasowe: 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
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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
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Overall survival (OS)
Ramy czasowe: 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
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Metabolic response on FDG-PET/CT
Ramy czasowe: At baseline and at 12 weeks
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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
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Molecular response on PSMA-PET/CT
Ramy czasowe: At baseline and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles)
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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)
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Best molecular response on quantitative 177Lu SPECT/CT during treatment
Ramy czasowe: From first cycle's Day 3 until the last cycle's Day 3 (each cycle is 6 weeks, up to 6 consecutive cycles)
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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)
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Number of participants with any adverse events (AEs)
Ramy czasowe: 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)
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Number of participants with laboratory adverse events (AEs)
Ramy czasowe: 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
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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
|
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Number of participants with delayed adverse events of special interest (AESIs)
Ramy czasowe: From date of first administration until the date of death, assessed over a minimum of 60 months
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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
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Jean-Mathieu Beauregard, MD, CHU de Québec-Université Laval
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-7829
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
There is an intent to create an imaging and data bank from this study.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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