PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

NCT03569241 | Active Not Recruiting Phase 2

• 1 other identifier: EC/2018/0130
• Study Type: interventional
• Target: 196
• Locations: 6 countries
• Sites: 29

Brief Summary

A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions).

Conditions

Prostate Cancer; Prostate Cancer Metastatic; Metastatic Cancer; Oligometastatic Cancer

Keywords

Radiotherapy; metastasis-directed therapy

Outcome Measures

Primary Outcomes (1)

• Metastases-free survival

  Metastasis-free survival will be defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by choline, FACBC or PSMA PET-CT or death due to any cause

  2 year

Secondary Outcomes (12)

• Clinical Progression free survival

  2 year

• Biochemical progression-free survival

  2 year

• Toxicity: acute toxicity

  3 months

• Toxicity: late toxicity

  2 year

• Patient reported QOL as per EORTC-QLQ C30

  2 year

Study Arms (2)

MDT + ADT

OTHER

Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + 6 months androgen deprivation therapy

Radiation: metastasis-directed treatment; Procedure: salvage Lymph Node Dissection; Drug: androgen deprivation therapy

MDT + WPRT + ADT

EXPERIMENTAL

Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + whole pelvic radiotherapy + 6 months androgen deprivation therapy

Radiation: whole pelvic radiotherapy; Radiation: metastasis-directed treatment; Procedure: salvage Lymph Node Dissection; Drug: androgen deprivation therapy

Interventions

whole pelvic radiotherapy RADIATION

addition of prophylactic whole pelvic radiotherapy to a local metastasis-directed treatment

MDT + WPRT + ADT

metastasis-directed treatment RADIATION

stereotactic body radiotherapy

MDT + ADT; MDT + WPRT + ADT

salvage Lymph Node Dissection PROCEDURE

metastasis-directed treatment

MDT + ADT; MDT + WPRT + ADT

androgen deprivation therapy DRUG

LHRH-agonist (+ anti-androgen) or antagonist for a duration of 6 months

MDT + ADT; MDT + WPRT + ADT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven initial diagnosis of adenocarcinoma of the prostate
• Biochemical relapse of prostate cancer following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/ salvage radiotherapy) according to the EAU guidelines 2016.
• Following radical prostatectomy, patients with a biochemical relapse are eligible in case a nodal relapse is detected in the pelvis even in the absence of prior postoperative prostate bed radiotherapy (adjuvant or salvage).
• In case of a suspected local recurrence following primary radiotherapy, a biopsy should confirm local recurrence and patients with a confirmed local recurrence are eligible in case they also undergo a local salvage therapy. If imaging rules out local relapse, patients are eligible.
• Nodal relapse in the pelvis on choline, PSMA or FACBC PET-CT with a maximum of 3 positive nodal lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.
• WHO performance state 0-1
• Age \>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.

You may not qualify if:

• Bone or visceral metastases
• Para-aortic lymph node metastases (above the aortic bifurcation)
• Local relapse in the prostate gland or prostate bed not suitable for a curative treatment
• Previous irradiation of the pelvic and or para-aortic nodes
• Serum testosterone level \<50ng/dl or 1.7 nmol/L at time of randomization
• Symptomatic metastases
• Lymph node metastases in previously irradiated areas resulting in dose constraint violation
• Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)
• Contraindications to androgen deprivation therapy
• PSA rise while on active treatment with (LHRH-agonist, LHRH-antagonist, anti-androgen, estrogen
• Previous treatment with cytotoxic agent for PCa
• Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
• Other active malignancy, except non-melanoma skin cancer or other malignancies with a documented disease-free survival for a minimum of 3 years before randomization.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Hospital, Geneva: collaborator

Study Sites (29)

Epworth Healthcare

Melbourne, Australia

Location

GZA

Antwerp, Belgium

Location

AZ St-Jan Brugge

Bruges, Belgium

Location

AZ St-Lucas

Bruges, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CH Mouscron

Mouscron, Belgium

Location

Humanitas Research Hospital

Milan, Italy

Location

Vita-Salute San Raffaele University

Milan, Italy

Location

Istituto Nazionale Tumori IRCCS

Napoli, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Location

Ospedale Sacro Cuore-Don Calabria

Verona, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

Cruces University Hospital

Barakaldo, Spain

Location

Clínica Universitaria IMQ

Bilbao, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Universitario Quironsalud

Madrid, Spain

Location

Hospitalario de Navarra

Navarro, Spain

Location

Hospital Clínico de Santiago

Santiago, Spain

Location

Hospital Universitari i Politècnic la Fe

Valencia, Spain

Location

Universitätsspital Basel

Basel, Switzerland

Location

Universitätsklinik für Radio-Onkologie

Bern, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

Related Publications (6)

• Ost P, Siva S, Brabrand S, Dirix P, Liefhooghe N, Otte FX, Gomez-Iturriaga A, Everaerts W, Shelan M, Conde-Moreno A, Lopez Campos F, Papachristofilou A, Guckenberger M, Scorsetti M, Zapatero A, Villafranca Iturre AE, Eito C, Counago F, Muto P, Duthoy W, Mach N, Fonteyne V, Moon D, Thon K, Mercier C, Achard V, Stellamans K, Goetghebeur E, Reynders D, Zilli T. Salvage metastasis-directed therapy versus elective nodal radiotherapy for oligorecurrent nodal prostate cancer metastases (PEACE V-STORM): a phase 2, open-label, randomised controlled trial. Lancet Oncol. 2025 Jun;26(6):695-706. doi: 10.1016/S1470-2045(25)00197-4. Epub 2025 May 5.

  PMID: 40339593 DERIVED

• Ost P, Siva S, Brabrand S, Dirix P, Liefhooghe N, Otte FX, Gomez-Iturriaga A, Everaerts W, Shelan M, Conde-Moreno A, Lopez Campos F, Papachristofilou A, Guckenberger M, Scorsetti M, Zapatero A, Villafranca Iturre AE, Eito C, Counago F, Muto P, Van De Voorde L, Mach N, Bultijnck R, Fonteyne V, Moon D, Thon K, Mercier C, Achard V, Stellamans K, Goetghebeur E, Reynders D, Zilli T. PEACE V-Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): Acute Toxicity of a Randomized Phase 2 Trial. Eur Urol Oncol. 2024 Jun;7(3):462-468. doi: 10.1016/j.euo.2023.09.007. Epub 2023 Oct 9.

  PMID: 37821242 DERIVED

• Huck C, Achard V, Zilli T. Surgical Treatments of Benign Prostatic Hyperplasia and Prostate Cancer Stereotactic Radiotherapy: Impact on Long-Term Genitourinary Toxicity. Clin Oncol (R Coll Radiol). 2022 Sep;34(9):e392-e399. doi: 10.1016/j.clon.2022.05.021. Epub 2022 Jun 15.

  PMID: 35715340 DERIVED

• Corkum MT, Achard V, Morton G, Zilli T. Ultrahypofractionated Radiotherapy for Localised Prostate Cancer: How Far Can We Go? Clin Oncol (R Coll Radiol). 2022 May;34(5):340-349. doi: 10.1016/j.clon.2021.12.006. Epub 2021 Dec 25.

  PMID: 34961659 DERIVED

• Zilli T, Dirix P, Heikkila R, Liefhooghe N, Siva S, Gomez-Iturriaga A, Everaerts W, Otte F, Shelan M, Mercier C, Achard V, Thon K, Stellamans K, Moon D, Conde-Moreno A, Papachristofilou A, Scorsetti M, Guckenberger M, Ameye F, Zapatero A, Van De Voorde L, Lopez Campos F, Counago F, Jaccard M, Spiessens A, Semac I, Vanhoutte F, Goetghebeur E, Reynders D, Ost P. The Multicenter, Randomized, Phase 2 PEACE V-STORM Trial: Defining the Best Salvage Treatment for Oligorecurrent Nodal Prostate Cancer Metastases. Eur Urol Focus. 2021 Mar;7(2):241-244. doi: 10.1016/j.euf.2020.12.010. Epub 2020 Dec 29.

  PMID: 33386290 DERIVED

• De Bruycker A, Spiessens A, Dirix P, Koutsouvelis N, Semac I, Liefhooghe N, Gomez-Iturriaga A, Everaerts W, Otte F, Papachristofilou A, Scorsetti M, Shelan M, Siva S, Ameye F, Guckenberger M, Heikkila R, Putora PM, Zapatero A, Conde-Moreno A, Counago F, Vanhoutte F, Goetghebeur E, Reynders D, Zilli T, Ost P. PEACE V - Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial. BMC Cancer. 2020 May 12;20(1):406. doi: 10.1186/s12885-020-06911-4.

  PMID: 32398040 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Piet Ost, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: April 27, 2018
• Primary Completion: April 30, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5); BE (9); IT (5); AU (1); ES (8); NO (1)