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PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

Study acronym: STORM
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Lead sponsor: University Ghent to University Hospital, Ghentv11
  2. Study completion date: Apr 30, 2025 to Dec 31, 2026v10
  3. Re-verified, no change to tracked fieldsv9
  4. Trial status: Recruiting to Active, Not Recruitingv8 Show 4 more changesShow less
    • Enrollment target: estimated 178 to confirmed 196
    • Primary completion date: Dec 31, 2023 to Apr 30, 2023
    • Study completion date: Dec 31, 2023 to Apr 30, 2025
    • Site details revised at 29 of 29 sites
  5. Secondary endpoints: 11 to 12
    • Study sites revised (29)
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 23 to 29v6
  2. Study sites: 21 to 23v5
  3. Study sites: 9 to 21v4
  4. Site details revised at 1 of 9 sitesv3
  5. Secondary endpoints: details revised at 1 of 11 entries
    • Study title shortened, about 7 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03569241
Lead Sponsor University Hospital, Ghent
Collaborators: University Hospital, Geneva
Conditions
(from sponsor)		 Prostate Cancer, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastatic Cancer
Related terms Neoplasm Metastasis, Prostatic Neoplasms
Enrollment 196 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov