NCT05352178RecruitingPhase 3
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?
Source: ClinicalTrials.gov · Last updated 3 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 873 (estimated)
- First submitted
- 22 Apr 2022
- Start date
- 20 Apr 2022
- Primary completion date
- 25 Apr 2027
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Prostate cancer
- NCT number
- NCT05352178
- EU CT number
- 2022-502373-42-00
- EudraCT number
- 2022-000066-18
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 873
- From 20 Apr 2022 to the primary completion date, 25 Apr 2027
- 15 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.
Other illness
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- 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.
- 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).
Lab values
- Serum testosterone level at castration level.
Other
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)
- Not able to understand the treatment protocol or sign informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Recruiting |
| Chu Helora Coordinator of this site? Confirm its status | La Louvière | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| A.Z. Sint-Maarten Coordinator of this site? Confirm its status | Mechelen | Belgium | Recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| CHR Verviers Coordinator of this site? Confirm its status | Verviers | Belgium | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.