None listed
Conditions
Interventions
Trade Name: NUBEQA
Product Name: ODM-201
Product Code: BAY1841788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Darolutamide
CAS Number: 1297538-32-9
Current Sponsor code: ODM-201
Other
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Histologically proven initial diagnosis of adenocarcinoma of the prostate ? Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy (RP), primary radiotherapy or the combination of RP and prostate bed adjuvant/ salvage radiotherapy) according to the EAU guidelines 2018. ? Following RP, patients with a biochemical relapse are eligible in case a metastatic relapse is detected even in the absence of prior postoperative prostate bed radiotherapy (adjuvant or salvage). In the absence of prior prostate bed radiotherapy, prostate bed radiotherapy is mandatory for all pT3a or higher or patients with a positive margin at time of RP. ? For patients without prior RP that have a suspected local recurrence following primary radiotherapy, a biopsy should confirm local recurrence. Patients with a confirmed local recurrence and metastases are eligible in case they also undergo a local salvage therapy. ? Metastatic relapse on PSMA PET-CT with a maximum of 5 metastases (any M1a, M1b or M1c). Concomitant diagnosis of N1 disease is allowed as long as all lesions are treated with SBRT and the total number of lesions does not exceed 5. PSMA positive lesions will be scored using the MI-RADS scoring system with lesions scored 4 or 5 considered positive19. ? Asymptomatic for metastatic PCa ? Age ? Histologically proven initial diagnosis of adenocarcinoma of the prostate ? Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy (RP), primary radiotherapy or the combination of RP and prostate bed adjuvant/ salvage radiotherapy) according to the EAU guidelines 2018. ? Following RP, patients with a biochemical relapse are eligible in case a metastatic relapse is detected even in the absence of prior postoperative prostate bed radiotherapy (adjuvant or salvage). In the absence of prior prostate bed radiotherapy, prostate bed radiotherapy is mandatory for all pT3a or higher or patients with a positive margin at time of RP. ? For patients without prior RP that have a suspected local recurrence following primary radiotherapy, a biopsy should confirm local recurrence. Patients with a confirmed local recurrence and metastases are eligible in case they also undergo a local salvage therapy. ? Metastatic relapse on PSMA PET-CT with a maximum of 5 metastases (any M1a, M1b or M1c). Concomitant diagnosis of N1 disease is allowed as long as all lesions are treated with SBRT and the total number of lesions does not exceed 5. PSMA positive lesions will be scored using the MI-RADS scoring system with lesions scored 4 or 5 considered positive19. ? Asymptomatic for metastatic PCa ? Age >=18 years ? WHO class 0-1 ? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial ? Before patient registration/randomization, written informed consent must be given in accordance with to ICH/GCP, and national/local regulations.18 years ? WHO class 0-1 ? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial ? Before patient registration/randomization, written informed consent must be given in accordance with to ICH/GCP, and national/local regulat
Exclusion criteria
Exclusion criteria: ? Local relapse in the prostate gland or prostate bed not suitable for a local salvage treatment ? Small cell carcinoma of the prostate ? PSA doubling time >12 months ? Serum testosterone level <50ng/dl or 1.7 nmol/L at time of randomization ? Currently receiving ADT or PSA rise while on active treatment with ADT (LHRH-agonist, LHRH-antagonist, anti-androgen or estrogen) within the past 6 weeks ? Spinal cord compression or impending spinal cord compression ? Metastases in previously irradiated areas precluding safe delivery of SBRT ? Contraindications to darolutamide ? Previous treatment with cytotoxic agent for PCa ? Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…) ? Other active malignancy, except non-melanoma skin cancer or other malignancies with a documented disease-free survival for a minimum of 3 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare (radiographic) metastasis-free survival (rPFS) between SBRT plus darolutamide and SBRT only for oligorecurrent PCa.;Secondary Objective: ? To describe the toxicity of both arms in patients with oligometastatic disease. ? To determine local control after SBRT + darolutamide in patients with oligometastatic disease. ? To assess biochemical relapse-free survival (BRFS) in both arms. ? To assess clinical progression-free survival (PFS) in both arms. ? To assess time to next systemic therapy in both arms ? To assess CRPC-free survival in both arms ? To assess PCa-specific and overall survival in both arms. ? To assess quality of life in both arms. ;Primary end point(s): Metastasis-free survival;Timepoint(s) of evaluation of this end point: week 12, week 24 and every 24 weeks until the event of interest has been reached | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 6.2.1. Clinical progression-free survival 6.2.2. Biochemical relapse-free survival 6.2.3. Time to next systemic therapy 6.2.4. Castrate resistant-free survival 6.2.5. Prostate cancer-specific survival 6.2.6. Overall survival 6.2.7. Acute and late toxicity 6.2.8. Quality of life ;Timepoint(s) of evaluation of this end point: o Clinical progression-free survival: week 12, week 24 and every 24 weeks until the event of interest has been reached. o Biochemical relapse-free survival: idem o Time to next systemic therapy: idem o Castrate resistant-free survival: idem o Prostate cancer-specific survival: idem o Overall survival: week 12, week 24 and every 24 weeks until the event of interest has been reached Acute and late toxicity: week 12 (acute toxicity), week 24 and every 24 weeks (i.e. late toxicity) until reaching the primary endpoint. Quality of life: ? At baseline (before randomization) ? At week 12 , week 24 and every 24 weeks thereafter until time of reaching the primary endpoint. | — |
Countries
Belgium
Contacts
Public ContactHIRUZ CTU
University Hospital Ghent
Outcome results
None listed