Surveillance or metastasis-directed Therapy for OligoMetastatic Prostate cancer recurrence (STOMP): study protocol for a randomized phase II trial

Abstract

BackgroundMetastases-directed therapy (MDT) with surgery or stereotactic body radiotherapy (SBRT) is emerging as a new treatment option for prostate cancer (PCa) patients with a limited number of metastases (≤3) at recurrence – so called “oligometastases”. One of the goals of this approach is to delay the start of palliative androgen deprivation therapy (ADT), with its negative impact on quality of life. However, the lack of a control group, selection bias and the use of adjuvant androgen deprivation therapy prevent strong conclusions from published studies.The aim of this multicenter randomized phase II trial is to assess the impact of MTD on the start of palliative ADT compared to patients undergoing active surveillance.Methods/DesignPatients with an oligometastatic recurrence, diagnosed on choline PET/CT after local treatment with curative intent, will be randomised in a 1:1 ratio between arm A: active surveillance only and arm B: MTD followed by active surveillance. Patients will be stratified according to the location of metastasis (node vs. bone metastases) and PSA doubling time (≤3 vs. > 3 months). Both surgery and SBRT are allowed as MDT. Active surveillance means 3-monthly PSA testing and re-imaging at PSA progression. The primary endpoint is ADT-free survival. ADT will be started in both arms at time of polymetastatic disease (>3 metastatic lesions), local progression or symptoms. The secondary endpoints include progression-free survival, quality of life, toxicity and prostate-cancer specific survival.DiscussionThis is the first randomized phase 2 trial assessing the possibility of deferring palliative ADT with MDT in oligometastatic PCa recurrence.Trial registrationClinicaltrials.gov identifier: NCT01558427

A population-based study of the clinical utility of 18F–choline PET/CT for primary metastasis staging of high-risk prostate cancer

“…Surgical removal of lymph node metastases and stereotactic radiation to oligo-metastatic spread to lymph nodes and bone in men with biochemical recurrence after radical local treatment have been associated with favorable outcomes in institutional series (Osmonov et al, 2016;Suardi et al, 2015;Pasqualetti et al, 2016), and there is at least one ongoing randomized controlled trial of metastasis-directed treatment of oligo-metastasis following recurrence after previous local therapy (Decaestecker et al, 2014). The favorable outcome after treatment of oligo-metastatic recurrence suggests that combined local and metastasisdirected therapies might be of benefit for men with primary oligo-metastatic disease, but results from randomized trials are needed to prove a survival benefit.…”

Methods for the diagnosis and treatment of oligometastases in patients with prostate cancer and progressive disease after radical treatment

“…Decaestecker и соавт. спланировали рандомизи-рованное исследование II фазы STOMP для оценки результатов лечения больных РПЖ с прогрессирова-нием опухолевого процесса после первичного лечения [45]. В него включали пациентов с повышением уров-ня ПСА, наличием до 3 метастазов в ЛУ или кости, диагностированных с помощью ПЭТ / КТ с холином, без признаков кастрационной резистентности.…”

Oligometastatic Prostate Cancer: Is it Real ?

“…For example, the ORIOLE trial randomizes patients with up to 3 mets and an hormone-naive disease to observation or SBRT [11]. Similarly, the STOMP trial from Belgium will examine surveillance or MDT for oligometastatic prostate cancer recurrence; it's a phase 2 randomized trial [15]. Of particular interest is the OLIGOPELVIS trial from GETUG group, a phase 2 multicenter trial of combined salvage RT and hormone therapy in oligometastatic pelvic node relapses [16].…”