Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

Recruiting Phase 3 Interventional Study
Prostate Cancer Prostate Cancer Recurrent Prostate Cancer Metastatic Metastatic Cancer Oligometastatic Disease Oligometastasis Hormone Sensitive Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
873 (estimated)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
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About This Trial
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 o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically proven initial diagnosis of prostate adenocarcinoma * Priory treated and controlled primary tumor * Biochemical recurrence defined by prostate-specific antigen (PSA) values \>0,2 ng/ml (i.e., two consecutive increases) following radical prostatectomy + postopera…
Contacts

Kato Rans, MD

003216340110

kato.rans@uzleuven.be

CONTACT

Gert De Meerleer, MD, PhD

003216347600

gert.demeerleer@uzleuven.be

CONTACT