Actively Recruiting
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
873
Participants Needed
1
Research Sites
522 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of prostate adenocarcinoma
- Previously treated and controlled primary tumor
- Biochemical recurrence with PSA values above 0.2 ng/ml (two consecutive increases) after radical prostatectomy and postoperative radiotherapy, or PSA rise of 2 ng/ml above nadir after high-dose radiotherapy
- Oligorecurrent disease with no more than 5 extracranial metastases diagnosed by PSMA PET-CT or PSMA PET-MRI
- Nodal (N1) disease included only if accompanied by M1a-c disease and total spots do not exceed 5
- Serum testosterone level within normal range
- WHO performance status 0 to 2
- Age 18 years or older
- No psychological, social, or geographical conditions affecting study compliance
- Approval for trial inclusion by multidisciplinary board
- Voluntary written informed consent obtained
- Use of highly effective birth control methods during the trial
You will not qualify if you...
- Any disorder risking participant safety or compliance as judged by investigator
- Prior or current treatments jeopardizing safety or trial integrity
- Participation in other interventional trials with investigational drugs or devices
- Serum testosterone at castration level
- PSA increase while on active hormone treatments
- Presence of more than 5 metastatic lesions (poly-metastatic disease)
- Active cancers other than prostate cancer interfering with trial
- Previous treatments or conditions preventing new SBRT treatment
- Contraindications for enzalutamide use such as seizure risk or recent significant cardiovascular disease
- Inability to understand treatment protocol or provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Belgium
Actively Recruiting
Research Team
K
Kato Rans, MD
CONTACT
G
Gert De Meerleer, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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