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Metastasis-directed therapy, whether or not in combination with hormone therapy, in patients with prostate cancer recurrence after initial treatment and a maximum of 5 metastases.
EU CTIS ID: 2022-502373-42-00
What this study is testing
The aim is to investigate whether the addition of short-term ADT during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to MDT significantly prolongs PMFS and/or mCRPC-FS. Metastatic castration-refractory prostate cancer free survival (mCRPCFS) will be calculated from the last day of MDT until the first day of diagnosis of castration-resistant prostate cancer (CRPC). CRPC is defined according to the contemporary EAU-guidelines as the time to biochemical and/or clinical progression at castrate testosterone levels (< 50 ng/dl). BcR is defined as two consecutive PSA rises (1 week interval), each with a value ≥ 25% increase above the nadir PSA level after treatment, and both with a PSA higher than the baseline PSA at inclusion in the study.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- 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. All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures.
- 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.
- Histologically proven initial diagnosis of prostatic adenocarcinoma.
- Priory treated and controlled primary tumor.
You likely can't join if
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Not able to understand the treatment protocol or sign informed consent.
- 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 (< 50 ng/dl or 1.7 nmol/L).
- PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen).
See the full eligibility criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- 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. All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures.
- 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.
- Histologically proven initial diagnosis of prostatic 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. 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 ≥ 50 ng/dl or 1.7 nmol/L (above castration level).
- WHO performance 0-2
- Age >= 18 years old
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Not able to understand the treatment protocol or sign informed consent.
- 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 (< 50 ng/dl or 1.7 nmol/L).
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.