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Adding radiotherapy to hormone therapy for prostate cancer that has come back

Tests radiotherapy added to enzalutamide and hormone therapy in men with recurring prostate cancer.

Key facts

Who runs it
Ente Ospedaliero Cantonale, Bellinzona
Where
Bordeaux, Lille, Saint-Etienne, Saint-Herblain, and Villejuif, FranceSee the 5 sitesAlso in 2 other countries, 14 sites
Trial code
Registry title
Best Salvage Treatment for High-risk Relapsing Prostate Cancer (PEACE-9 - ESCALATE-RT)
Status
Not yet recruiting
Phase
Phase 3
People taking part
140 people, planned
Started
Nov 2026
Expected to end
Jul 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Radiotherapy for MDT ± WPRT
  • Androgen Deprivation Therapy (ADT)
  • Enzalutamide
Record updated
24 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men whose prostate cancer has come back after local treatment, with a rising PSA and 1 to 5 areas of cancer spread seen on a PSMA PET/CT scan.

Age
18 years or older
Sex
Men only
Disease stage
Prostate adenocarcinoma with rising PSA after local therapy (PSA 0.2 ng/mL or higher after surgery, or at least 2 ng/mL above the lowest level after primary radiotherapy, with PSADT 9 months or less). 1 to 5 distant metastases on PSMA PET/CT, with or without pelvic lymph node involvement. ECOG performance status 0 to 2.
Earlier treatment
Must have had local therapy for the prostate cancer. No earlier hormone therapy, except treatment of 36 months or less that ended at least 9 months before randomization. No earlier chemotherapy for prostate cancer.
Biomarker or test result
Serum testosterone of 150 ng/dl or higher. Rising PSA with PSADT of 9 months or less.

Main reasons for not taking part

  • More than 5 distant PSMA-positive metastases, or brain or leptomeningeal metastases
  • Cancer back in the prostate or prostate bed after earlier radiotherapy
  • Earlier signs of distant metastatic disease
  • Cannot have pelvic radiotherapy, metastasis-directed radiotherapy, ADT or enzalutamide
  • Another active cancer in the previous 36 months, with a few exceptions

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior evidence of distant metastatic disease
  • 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
  • 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
  • More than 5 distant PSMA positive metastases and/or brain or leptomeningeal metastases
  • Contraindications to pelvic RT and/or MDT
  • Contraindications to ADT

Where in France

Also in 2 other countries, 14 sites

  • Institut BergonieBordeaux, FranceContact: Vérane Achard, MD, PhDNot yet recruiting
  • Centre Oscar LambretLille, FranceContact: David Pasquier, MD, PhDNot yet recruiting
  • Chu de Saint EtienneSaint-Etienne, FranceContact: Nicolas Vial, MDNot yet recruiting
  • Institut de Cancérologie de l'OuestSaint-Herblain, FranceContact: Stéphane Supiot, MD, PhDNot yet recruiting
  • Institut Gustave RoussyVillejuif, FranceContact: Pierre Blanchard, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • ADT plus EnzalutamideExisting treatment, for comparison

    Enzalutamide 160 mg daily + androgen deprivation therapy for 9 months, suspended if PSA \< 0.2 ng/mL, followed by PSA monitoring until progression

    Treatment: Androgen Deprivation Therapy (ADT) and Enzalutamide

  • ADT plus Enzalutamide plus Radiotherapy (MDT +/- WPRT)Treatment being tested

    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

    Treatment: Radiotherapy for MDT ± WPRT, Androgen Deprivation Therapy (ADT), and Enzalutamide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Adding radiotherapy to hormone therapy for prostate cancer that has come backGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
24 August 2026