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
- Aalst, Anderlecht, Brugge, Gent, Kortrijk, La Louvière, Leuven, Mechelen, Roeselare, Sint-Lambrechts-Woluwe, and Verviers, BelgiumSee the 12 sites
- Phase
- Phase 3
Where in Belgium
- Onze-Lieve-VrouwziekenhuisAalst, BelgiumTaking people
- Institut Jules BordetAnderlecht, BelgiumTaking people
- Az St-Jan Brugge-Oostende A.V.Brugge, BelgiumTaking people
- Az Maria Middelares GentGent, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- Algemeen Ziekenhuis GroeningeKortrijk, BelgiumTaking people
- Chu HeloraLa Louvière, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- A.Z. Sint-MaartenMechelen, BelgiumTaking people
- AZ DeltaRoeselare, BelgiumTaking people
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
- CHR VerviersVerviers, BelgiumTaking people
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?
Trial 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.