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Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

Study acronym: SPARKLE
StatusRecruiting
PhasePhase 3
Started2022-04-20
View on ClinicalTrials.gov ↗

Amendment history

2024-07-01
2 amendments v2-v3
2 re-verifications since 2022-06-07, no change to tracked fields
2022-05-03
Active, Not Recruiting→Recruiting Study Identification, Study Status, Study Description, Contacts/Locations v1
Trial statusActive, Not Recruiting→Recruiting
Study descriptionrevised
[...] so in low-volume metastatic disease. In this clinical trial ourthe aim is to investigate whether the addition of short-term AD [...]
Study sitesdetails revised at 1 of 1 site
Study title-30 characters
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer: a Randomized Phase III Trial
2022-04-22
Original filing
The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.
Trial Details
NCT Number NCT05352178
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastatic Disease, Oligometastasis, Hormone Sensitive Prostate Cancer
Enrollment 873 participants
Start Date 2022-04-20
Primary Completion 2027-04-25 (estimated)
Study Completion 2032-04-25 (estimated)
Updated on ClinicalTrials.gov 2024-07-03