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

21 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Droga: 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.
Droga: 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.
Sperimentale: 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
Droga: 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.
Droga: 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.
Radiazione: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first re-initiation of treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to PSA progression
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Collaboratori

Clinical Trial Unit Ente Ospedaliero Cantonale

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 luglio 2030

Completamento dello studio (Stimato)

1 luglio 2030

Date di iscrizione allo studio

Primo inviato

19 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 agosto 2026

Primo Inserito (Effettivo)

24 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PEACE-9 - ESCALATE-RT

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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