Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03569241
PHASE2

PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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).

Official title: PEACE V: a Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2018-04-27

Completion Date

2026-12-31

Last Updated

2024-12-09

Healthy Volunteers

No

Interventions

RADIATION

whole pelvic radiotherapy

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

RADIATION

metastasis-directed treatment

stereotactic body radiotherapy

PROCEDURE

salvage Lymph Node Dissection

metastasis-directed treatment

DRUG

androgen deprivation therapy

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

Locations (29)

Epworth Healthcare

Melbourne, Australia

GZA

Antwerp, Belgium

AZ St-Jan Brugge

Bruges, Belgium

AZ St-Lucas

Bruges, Belgium

Institut Jules Bordet

Brussels, Belgium

University Hospital Ghent

Ghent, Belgium

AZ Maria Middelares

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

CH Mouscron

Mouscron, Belgium

Humanitas Research Hospital

Milan, Italy

Vita-Salute San Raffaele University

Milan, Italy

Istituto Nazionale Tumori IRCCS

Naples, Italy

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Ospedale Sacro Cuore-Don Calabria

Verona, Italy

Oslo University Hospital

Oslo, Norway

Cruces University Hospital

Barakaldo, Spain

Clínica Universitaria IMQ

Bilbao, Spain

Hospital Ramón y Cajal

Madrid, Spain

Hospital Universitario La Princesa

Madrid, Spain

Universitario Quironsalud

Madrid, Spain

Hospitalario de Navarra

Navarro, Spain

Hospital Clínico de Santiago

Santiago, Spain

Hospital Universitari i Politècnic la Fe

Valencia, Spain

Universitätsspital Basel

Basel, Switzerland

Universitätsklinik für Radio-Onkologie

Bern, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

UniversitätsSpital Zürich

Zurich, Switzerland