NCT05352178 Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
| NCT ID | NCT05352178 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 873 participants |
| Start Date | 2022-04-20 |
| Primary Completion | 2027-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 873 participants in total. It began in 2022-04-20 with a primary completion date of 2027-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 + postoperative radiotherapy and a PSA value of 2 ng/ml above the nadir after high-dose RT. * Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5. * Serum testosterone level within normal range. * WHO performance 0-2 * Age \>= 18 years old * Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol. * Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board. * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * 2\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. Exclusion Criteria: * Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol * Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial * Participation in an interventional Trial with an investigational medicinal product (IMP) or device * Serum testosterone level at castration level. * PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen) * Presence of poly-metastatic disease, defined as more than 5 metastatic lesions. * Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial. * Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible. * Contra indications for intake of enzalutamide (seizure or any condition that may predispose to seizure; significant cardiovascular disease within the last three months including myocardial infarction, unstable angina, congestive heart failure, ongoing arrythmias of grade \> 2 or a thromboembolic event). * Not able to understand the treatment protocol or sign informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05352178 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05352178 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 873 participants.
Is NCT05352178 currently recruiting?
Yes, NCT05352178 is actively recruiting participants. Contact the research team at kato.rans@uzleuven.be for enrollment information.
Where is the NCT05352178 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05352178 clinical trial?
NCT05352178 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 873 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.