Adding hormone drugs to targeted treatment for limited prostate cancer spread
Tests hormone-lowering drugs with targeted treatment in adults with a few prostate cancer spots.
Plain-language title generated from the registry record
Registry title: Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
Key facts
- Where
- Florence, Milan, and Monza, ItalySee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men whose prostate cancer came back after treatment and has spread to at most 5 places outside the brain. It tests adding hormone treatment to targeted radiotherapy or surgery.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma that came back (PSA rising) with at most 5 metastases outside the brain, seen on a PSMA PET scan. Testosterone must be in the normal range.
- Earlier treatment
- The first (primary) tumor must have been treated and controlled, by prostate removal plus radiotherapy or by high-dose radiotherapy. Cannot have a PSA rise while on hormone treatment.
- Biomarker or test result
- PSA above 0,2 ng/ml (two rises in a row) after prostate removal plus radiotherapy, or 2 ng/ml above the lowest value after high-dose radiotherapy.
Main reasons for not taking part
- More than 5 metastatic lesions
- Testosterone at castration level
- Another active cancer that could interfere with the trial
- Earlier treatment or illness that makes SBRT radiotherapy impossible
- Seizures or recent serious heart problems (enzalutamide cannot be taken)
Read by machine on 12 November 2026.
Where in Italy
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNot yet recruiting
- Istituto Europeo di Oncologia s.r.lMilan, ItalyNot yet recruiting
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT05352178EU 2022-502373-42-00
- Record updated
- 3 July 2024
- Original description
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.Read full original descriptionShow less
a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?
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.
Inclusion: 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: 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; 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); Serum testosterone level at castration level; 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.