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Best Salvage Treatment for High-risk Relapsing Prostate Cancer (PEACE-9 - ESCALATE-RT) (ESCALATE-RT)

21 sierpnia 2026 zaktualizowane przez: Thomas Zilli, Ente Ospedaliero Cantonale, Bellinzona

PEACE-9 - ESCALATE-RT: A Phase III Randomized Study in Patients With High-risk PSA Relapse After Local Therapy Treated With Enzalutamide Plus Androgen Deprivation Therapy and Comparing MDT ± Pelvic Radiotherapy Versus no Further Treatment

The goal of this clinical trial is to learn if adding metastasis-directed radiotherapy with or without pelvic salvage radiotherapy, to intermittent prostate cancer drugs (intensified hormone therapy) can delay the need to restart these drugs in men with oligometastactic prostate cancer recurrence.

In practice, this study is open to men whose PSA level (a blood marker of cancer activity) is rising as defined by biochemical recurrence, and who have 1 to 5 areas of cancer spread (1 to 5 metastases defining oligometastatic status) found on a specialized scan (PSMA PET/CT).

Since intensified hormone therapy, including androgen deprivation therapy combined with a next-generation hormone therapy, represents the standard treatment strategy for these patients, researchers want to find out if adding radiation therapy can help patients to spend more time off cancer drugs while keeping their cancer under control.

The main questions this trial aims to answer are:

  • Does adding radiation therapy to each metastases with or without pelvic area, lengthen the time before participants need to restart drug treatment?
  • Does adding radiation therapy increase the number of participants whose PSA drops to a very low level (0.2 ng/mL or lower)?
  • Does adding radiation therapy affect participants' quality of life?

Researchers will randomly assign participants (chosen by chance) to receive either enzalutamide (next-generation hormone therapy) plus androgen-deprivation therapy (first-generation hormone therapy ) alone, or the same association of these drugs combined with radiation therapy aimed at each metastases with or without pelvic area.

This comparison will show whether adding radiation therapy helps participants reach a deeper PSA response and go longer without needing cancer drugs.

Participants will:

  • Take enzalutamide and androgen-deprivation therapy for 9 months
  • Have an equal chance of also receiving radiation therapy to each metastases with or without pelvic area
  • Stop drug treatment after 9 months if their PSA drops below 0.2 ng/mL, a level showing the cancer is well controlled
  • Restart drug treatment if their PSA rises again during the treatment-free period
  • Have regular blood tests and clinic visits to check their PSA, testosterone, and overall health
  • Complete short quality-of-life questionnaires during the study
  • Take part in a study conducted at several hospitals in Switzerland, Belgium, and France.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

140

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Belgia
      • Aalst, Belgia
        • AZorg Aalst
        • Kontakt:
          • Mark De Ridder, MD
      • Antwerp, Belgia
        • Iridium Netwerk
        • Kontakt:
          • Piet Ost, MD, PhD
      • Bruges, Belgia
        • AZ Sint-Jan
        • Kontakt:
          • Sarah Roels, MD
      • Brussels, Belgia
        • Institut Bordet - HUB Brussel
        • Kontakt:
          • Dirk Van Gestel, MD
      • Hasselt, Belgia
        • Jessa Ziekenhuis
        • Kontakt:
          • Philippe Bulens, MD
      • Kortrijk, Belgia
        • AZ Groeninge
        • Kontakt:
          • Aurélie De Bruycker, MD
      • Mechelen, Belgia
        • AZ Sint-Maarten Mechelen
        • Kontakt:
          • Cédric Draulans, MD
  • Francja
      • Bordeaux, Francja
        • Institut Bergonie
        • Kontakt:
          • Vérane Achard, MD, PhD
      • Lille, Francja
        • Centre Oscar Lambret
        • Kontakt:
          • David Pasquier, MD, PhD
      • Saint-Etienne, Francja
      • Saint-Herblain, Francja
        • Institut de Cancérologie de l'Ouest
        • Kontakt:
          • Stéphane Supiot, MD, PhD
      • Villejuif, Francja
        • Institut Gustave Roussy
        • Kontakt:
          • Pierre Blanchard, MD, PhD
  • Szwajcaria

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Histologically proven initial diagnosis of adenocarcinoma of the prostate
  • Rising PSA after local therapy as defined by PSA ≥ 0.2 ng/mL after RP +/- adjuvant/salvage prostate bed RT and at least 2 ng/mL above nadir for primary RT, with a PSADT ≤ 9 months
  • Serum Testosterone ≥ 150 ng/dl (6.9343 nM/L)
  • On PSMA PET/CT restaging presence of: 1 to 5 distant metastases that are amenable to MDT ± N1 patients (no limit in the number of nodes)
  • ECOG performance status 0 - 2
  • Age > or =18 years
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria:

  • More than 5 distant PSMA positive metastases and/or brain or leptomeningeal metastases.
  • Prostate recurrence (positive PSMA disease) after primary prostate irradiation
  • Prostate bed recurrence (positive PSMA disease) after salvage/adjuvant irradiation
  • Pelvic nodal recurrence (positive PSMA disease) after primary WPRT irradiation
  • Contraindications to pelvic RT and/or MDT
  • Prior evidence of distant metastatic disease
  • Contraindications to ADT
  • Contraindication for treatment with enzalutamide
  • Prior hormonal therapy (Neoadjuvant/adjuvant therapy to treat PCa ≤ 36 months in duration and ≥ 9 months before randomization is allowed)
  • Previous treatment with cytotoxic agent for PCa
  • Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: ADT plus Enzalutamide
Enzalutamide 160 mg daily + androgen deprivation therapy for 9 months, suspended if PSA < 0.2 ng/mL, followed by PSA monitoring until progression
Lek: Androgen Deprivation Therapy (ADT)
  • All arms should receive ADT for a duration of at least 36 weeks.
  • The prescription of ADT in both treatment arms will be in accordance with standard practice for the indication, the chosen molecules, and the selected doses.

  • ADT should be suspended at the end of week 36, if PSA < 0.2 ng/mL at week 36. In the off-period, ADT will be restarted with a rise of PSA to ≥ 5 ng/mL after primary RT or to ≥ 2 ng/mL after RP ± postoperative RT. For patients in the off-period with rising PSA < 5 ng/mL after primary RT or < 2ng/mL after RP

    • postoperative RT, the decision to restart treatment is led to each investigator.
  • ADT should be continued until progression at the end of week 36, if PSA ≥ 0.2 ng/mL at week 36.
Lek: Enzalutamide
  • All arms should receive enzalutamide 160mg daily for a duration of at least 36 weeks.
  • Enzalutamide should be suspended at the end of week 36, if PSA < 0.2 ng/mL at week 36. In the off-period, Enzalutamide will be restarted with a rise of PSA to ≥ 5 ng/mL after primary RT or to ≥ 2 ng/mL after RP ± postoperative RT. For patients in the off-period with rising PSA < 5 ng/mL after primary RT or < 2ng/mL after RP ± postoperative RT, the decision to restart treatment is led to each investigator.
  • Enzalutamide should be continued until progression at the end of week 36, if PSA ≥ 0.2 ng/mL at week 36.
Eksperymentalny: ADT plus Enzalutamide plus Radiotherapy (MDT +/- WPRT)
Enzalutamide 160 mg daily + androgen deprivation therapy for 9 months, suspended if PSA < 0.2 ng/mL, followed by PSA monitoring until progression + Radiotherapy for MDT ± WPRT
Lek: Androgen Deprivation Therapy (ADT)
  • All arms should receive ADT for a duration of at least 36 weeks.
  • The prescription of ADT in both treatment arms will be in accordance with standard practice for the indication, the chosen molecules, and the selected doses.

  • ADT should be suspended at the end of week 36, if PSA < 0.2 ng/mL at week 36. In the off-period, ADT will be restarted with a rise of PSA to ≥ 5 ng/mL after primary RT or to ≥ 2 ng/mL after RP ± postoperative RT. For patients in the off-period with rising PSA < 5 ng/mL after primary RT or < 2ng/mL after RP

    • postoperative RT, the decision to restart treatment is led to each investigator.
  • ADT should be continued until progression at the end of week 36, if PSA ≥ 0.2 ng/mL at week 36.
Lek: Enzalutamide
  • All arms should receive enzalutamide 160mg daily for a duration of at least 36 weeks.
  • Enzalutamide should be suspended at the end of week 36, if PSA < 0.2 ng/mL at week 36. In the off-period, Enzalutamide will be restarted with a rise of PSA to ≥ 5 ng/mL after primary RT or to ≥ 2 ng/mL after RP ± postoperative RT. For patients in the off-period with rising PSA < 5 ng/mL after primary RT or < 2ng/mL after RP ± postoperative RT, the decision to restart treatment is led to each investigator.
  • Enzalutamide should be continued until progression at the end of week 36, if PSA ≥ 0.2 ng/mL at week 36.
Promieniowanie: Radiotherapy for MDT ± WPRT

Participants receive metastasis-directed therapy (MDT) alone or combined with prostate-bed radiotherapy (PB-RT) and/or whole pelvic radiotherapy (WPRT), as follows (radiotherapy is tailored to each participant's prior curative treatment for prostate cancer, to avoid re-irradiating previously treated volumes) :

  • Prior radical prostatectomy (RP) alone: MDT plus PB-RT, with or without WPRT. WPRT is mandatory for pelvic nodal involvement (N1) and recommended for node-negative (N0) participants.
  • Prior RP plus PB-RT: MDT, with or without WPRT. WPRT is mandatory for N1 and recommended for N0 participants.
  • Prior RP plus PB-RT plus WPRT: MDT alone.
  • Prior definitive prostate radiotherapy (no prostatectomy): MDT, with or without WPRT. WPRT is mandatory for N1 and recommended for N0 participants.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to first re-initiation of treatment
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date

• Time to first re-initiation of treatment calculated from randomization to the occurrence of one of the following events:

  • PSA ≥ 0.2 ng/mL at week 36 (treatment is continued until progression),
  • For patients in the off-period, a rise of PSA to ≥ 5 ng/mL after primary RT or to ≥ 2 ng/mL after RP ± postoperative RT (treatment is restarted as per EMBARK criteria)
  • For patients in the off-period with rising PSA < 5 ng/mL after primary RT or <2ng/mL after RP ± postoperative RT, the investigator decision to start same or new treatment.

Death in the absence of progressive disease will be considered as a competing risk for this endpoint.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to PSA progression
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Time to PSA progression: defined by the time from the day of PSA nadir and the day when the PSA increase of ≥ 25% and an absolute increase of ≥ 2 ng/mL above the nadir.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
PFS (Progression-Free Survival)
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
PFS: defined as the time from randomization to the first progression or death (progression being defined by the appearance of a new recurrence (any N1 or M1) as suggested by PET-CT, or symptoms related to progressive prostate cancer, or death due to any cause).
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
MFS (Metastasis-Free Survival)
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
MFS: defined as time between randomization and the appearance of a new metastatic recurrence (any M1) as suggested by PET-CT, or death due to any cause.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
OS (Overall Survival)
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
OS: defined as the time from randomization to death to any cause.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
PSA response
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
PSA response: defined by a PSA < 0.2 ng/ml at 9 months.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Pattern of progression
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date

Local/regional/distant recurrence will be analyzed:

  • A local recurrence is defined as the appearance of evidence of a recurrence on imaging inside a PTV_M volume or the PTV_PB volume or the PTV_LNN.
  • A regional nodal recurrence is defined as the appearance of evidence of a lymphadenopathy in the pelvis but outside the PTV_LNN volume, in a patient without the diagnosis of hematologic/lymphatic disorder associated with lymphadenopathy or if there is histopathological evidence.
  • Distant recurrence is defined as the appearance of evidence of a lymphadenopathy outside the PTV_LNN and outside all the PTV_M (for lymph nodes previously treated as metastasis), or distant metastases (M1b, M1c) outside all the PTV_M.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Time to castration-resistant disease
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Time to castration-resistant disease is defined as the time from trial randomization until castration-resistant status, defined as a castrate serum testosterone level below 50 ng/dL (1.7 nmol/L) plus either biochemical progression or radiological progression. Biochemical progression is defined as three consecutive rises in PSA at least 1 week apart, resulting in two 50% increases over the nadir, with a PSA level above 2 ng/mL. Radiological progression is defined as the appearance of two or more new bone lesions on bone scan, or enlargement of a soft tissue lesion using RECIST (Response Evaluation Criteria in Solid Tumours). Symptomatic progression alone is not sufficient to diagnose castration-resistant prostate cancer (CRPC).
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Adverse events
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Adverse events: acute (during the first 3 months after the end of MDT ± WPRT and late (3 months after the end of MDT ± WPRT).
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Quality of life (QoL) - EORTC QLQ-C30
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), version 3, a 30-item questionnaire. Items are rated on a 4-point scale (1 = "Not at all" to 4 = "Very much"), except the two global health status/QoL items, rated on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Raw scores are linearly transformed to a 0-100 scale. Higher scores indicate better functioning/quality of life on the functional and global health scales, and greater symptom burden on the symptom scales.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Quality of Life - EORTC QLQ-PR25
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
EORTC Quality of Life Questionnaire Prostate Cancer Module (QLQ-PR25), a 25-item module supplementing the QLQ-C30. Items are rated on a 4-point scale (1 = "Not at all" to 4 = "Very much"). Raw scores are linearly transformed to a 0-100 scale. Higher scores indicate greater symptom burden, except for sexual activity/functioning scales, where higher scores indicate better functioning.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
Quality of Life - EORTC IL-249
Ramy czasowe: From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date
A customised 22-item list from the EORTC IL-249, assessing general symptoms, weight-related issues, and sexual quality of life. Items are rated on a 4-point scale (1 = "Not at all" to 4 = "Very much"). Raw scores are linearly transformed to a 0-100 scale; higher scores indicate a greater burden of symptoms or issues.
From the start of Androgen Deprivation Therapy plus Enzalutamide to 5 years after this date

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Współpracownicy

Clinical Trial Unit Ente Ospedaliero Cantonale

Śledczy

  • Główny śledczy: Thomas Zilli, MD, IOSI-EOC
  • Krzesło do nauki: Bertrand Tombal, MD, PhD, Urology, Cliniques Universitaires Saint Luc, Bruxelles, Belgium
  • Krzesło do nauki: Piet Ost, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Department of Radiation Oncology, Iridium Network, Wilrijk, Belgium
  • Krzesło do nauki: Silke Gillessen, MD, IOSI-EOC
  • Krzesło do nauki: Piet Dirix, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Belgium
  • Krzesło do nauki: Salvatore Cozzi, MD, IOSI-EOC
  • Krzesło do nauki: Nicolas Vial, MD, University Hospital of Saint-Etienne

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 listopada 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2030

Ukończenie studiów (Szacowany)

1 lipca 2030

Daty rejestracji na studia

Pierwszy przesłany

19 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

24 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PEACE-9 - ESCALATE-RT

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

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