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 metastasen.
- Conditions
- Oligorecurrent hormone-sensitive prostate cancer patientsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-000066-18-BE
- Lead Sponsor
- niversitaire Ziekenhuizen Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 873
Participants eligible for inclusion in this Trial must meet all of the following criteria:
1.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.
3.Histologically proven initial diagnosis of prostatic adenocarcinoma.
4.Priory treated and controlled primary tumor.
5.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 (25).
6.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.
7.Serum testosterone level within normal range.
8.WHO performance 0-2
9.Age >= 18 years old
10.Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol.
11.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 573
Participants eligible for this Trial must not meet any of the following criteria:
1.Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
2.Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
3.Participation in an interventional Trial with an investigational medicinal product (IMP) or device
4.Serum testosterone level at castration level.
5.PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)
6.Presence of poly-metastatic disease, defined as more than 5 metastatic lesions.
7.Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.
8.Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.
9.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).
10.Not able to understand the treatment protocol or sign informed consent.
Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled/randomized in the Trial and will be identified on the Screening Log as Screen Failure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method