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

21. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

140

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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
Arzneimittel: 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.
Arzneimittel: 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.
Experimental: 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
Arzneimittel: 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.
Arzneimittel: 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.
Strahlung: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to first re-initiation of treatment
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to PSA progression
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Mitarbeiter

Clinical Trial Unit Ente Ospedaliero Cantonale

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. Juli 2030

Studienabschluss (Geschätzt)

1. Juli 2030

Studienanmeldedaten

Zuerst eingereicht

19. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. August 2026

Zuerst gepostet (Tatsächlich)

24. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PEACE-9 - ESCALATE-RT

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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