Clinical Research Directory
Browse clinical research sites, groups, and studies.
PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases
Sponsor: University Hospital, Ghent
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
whole pelvic radiotherapy
addition of prophylactic whole pelvic radiotherapy to a local metastasis-directed treatment
metastasis-directed treatment
stereotactic body radiotherapy
salvage Lymph Node Dissection
metastasis-directed treatment
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