Personalizovaná vs. pevná aktivita 177LU-PSMA-617 Radiofarmaceutická terapie (Prodigy-2) (PRODIGY-2)
Prostata specifická membránová antigen dozimetrie-vedená endoradioterapie: randomizovaná, slepá, slepá, pilotní studie personalizované vs. fixní aktivity 177LU-PSMA-617 radiofarmaceutická terapie (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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Marie-Christine Dubé, Ph.D.
- Telefonní číslo: 418-525-4444
- E-mail: marie-christine.dube@crchudequebec.ulaval.ca
Studijní místa
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Quebec
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Québec, Quebec, Kanada, G1R2J6
- Nábor
- CHU de Québec-Université Laval
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Kontakt:
- Marie-Christine Dubé, Ph.D.
- Telefonní číslo: 418-525-4444
- E-mail: marie-christine.dube@crchudequebec.ulaval.ca
-
Vrchní vyšetřovatel:
- Jean-Mathieu Beauregard, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Personalizovaná činnost
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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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Aktivní komparátor: Pevná aktivita
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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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Administered activity of 177Lu-PSMA-617
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Variace skóre na dotazníku EUROQOL-5 Dimension-5 (EQ-5D-5L) ve výchozím stavu
Časové okno: Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
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Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
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Variace skóre při funkčním hodnocení terapie rakoviny - dotazník prostaty (fakt -p) na začátku studie
Časové okno: Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
|
Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
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Variace skóre na dotazníku s krátkými inventářemi bolesti (BPI-SF) na začátku studie
Časové okno: Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
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Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
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Variace skóre na dotazníku Multidisciplinary Slivary Gland Society (MSGS) na počátku na počátku
Časové okno: Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
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Na začátku 18 týdnů a na konci léčby (každý cyklus je 6 týdnů, až 6 po sobě jdoucích cyklů)
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Best biochemical response
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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 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)
Časové okno: 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)
Časové okno: From date of first administration until the date of death, assessed over a minimum of 60 months
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
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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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jean-Mathieu Beauregard, MD, CHU de Québec-Université Laval
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-7829
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
There is an intent to create an imaging and data bank from this study.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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