Oligorecurrent hormone-sensitive prostate cancer patients
Conditions
Interventions
Trade Name: Zoladex 3,6 mg implant
Pharmaceutical Form: Implant in pre-filled syringe
INN or Proposed INN: GOSERELIN ACETATE
Other descriptive name: GOSERELIN ACETATE
Concentration unit: mg milligram(
Sponsors
Universitaire Ziekenhuizen Leuven
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (mCRPC-FS) 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 ( 2 ng/ml and a rise of 50% above the nadir PSA level. ;Secondary Objective: - Biochemical progression-free survival will be calculated from the last day of MDT until the first day of biochemical relapse (BcR). BcR is defined as three consecutive PSA rises (1 week interval), of which at least 2 rises with a PSA level of > 2 ng/ml and a rise of 50% above the nadir PSA level. - Clinical progression free survival will be calculated from the last day of MDT until the first day of progression on PSMA PET-CT/MRI. - Cancer specific survival will be calculated from last day of treatment until PCa death. - Overall survival will be calculated from last day of treatment until death from any cause. - Acute and late toxicity as a result of radiotherapy will be scores using the Common Toxicity Criteria Version 5.0. - Quality of life scoring using the EORTC QLQ-C30 supplement with QLQ-PR25. We will assess the quality-of-life-years with the EuroQOL classification system (EQ-5D-5L). ;Primary end point(s): Poly-metastatic free survival (PMFS) will be calculated from the last day of MDT until the first day of poly-progression which is defined as the detection > 5 new lesions at PSMA PET-CT or PSMA PET-MRI (+/- combined with MRI if needed to improve diagnostic accuracy). In case of poly-progression, pADT will be considered the standard-of-care. Other indications to start pADT are local progression of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. Metastatic castration-refractory prostate cancer free survival (mCRPC-FS) mCRPC-FS 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 ( 2 ng/ml and a rise of 50% above the nadir PSA level (28). b. Biochemical progression-free survival (bPFS) bPFS will be calculated from the last day of MDT until the first day of biochemical relapse (BcR). BcR is defined as three consecutive PSA rises (1 week interval), of which at least 2 rises with a PSA level of > 2 ng/ml and a rise of 50% above the nadir PSA level. c. Clinical progression free survival (cPFS) cPFS will be calculated from the last day of MDT until the first day of progression (local, nodal or metastatic) on PSMA PET-CT or PSMA PET-MRI. Imaging is performed in case of BcR, defined as above. Progression on PSMA PET-CT or PSMA PET-MRI will be defined as in the consensus statements on PSMA PET-CT or PSMA PET-MRI response assessment criteria in prostate cancer(29): - the appearance of 2 or more new PSMA PET-CT or PSMA PET-MRI lesions or increase of uptake or tumor PET volume of at least 30%. - OR the appearance of 1 new lesion with a high suspicion on PSMA PET-CT or PSMA PET-MRI. d. Cancer Specific Survival (CSS) Cancer specific survival (CSS) will be calculated from last day of treatment until PCa death. e. Overall Survival (OS) Overall survival (OS) will be calculated from last day of treatment until death from any cause. f. Acute and late toxicity scoring Acute and late toxicity as a result of radiotherapy will be scores using the Common Toxicity Criteria Version 5.0 (30). Toxicity will be scored at every follow-up visit. g. Quality of life (QOL) Quality of life scoring using the EORTC QLQ-C30 supplement with QLQ-PR25. We will assess the quality-of-life-years wit | — |
Countries
Belgium
Contacts
Public ContactSub-Investigator Dr. Rans Kato
Universitaire Ziekenhuizen Leuven
Outcome results
None listed