Prostate cancer
Conditions
Brief summary
Phase 3 Intensification study: Incidence of ppMFS over time. PSMA PET metastatic progression is defined as the appearance of at least 1 new PSMA-PET-positive distant lesion compared with the baseline scan or date of death from any cause., Phase 2 De-intensification study: Health related Quality of Life (HRQL) will be reported by subjects using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. A clinically important point reduction in EPIC subdomain score is defined as follows: sexual (11 points), and hormonal (5 points) as detected at 12 months. EPIC scores will be measured on a yearly basis to monitor late effects.
Detailed description
OS will be measured from the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, Prostate cancer-specific mortality (PCSM) will be measured from the date of randomization to the date of prostate cancer death., Biochemical progression-free survival will be measured from the date of randomization to the date event, or death or censored at the last known follow-up date. Events are PSA failure, castrate resistance (EAU Guidelines on Prostate Cancer 2022), receiving salvage therapy, or death from any cause., Time to next systemic therapy (NEST) will be measured from date of randomization to time of death, or censored at the last known follow-up date. Events for NEST are receiving any local therapy (surgery, radiotherapy, HIFU, cryotherapy) or systemic therapy for prostate cancer., Counts of all AEs by grade will be provided by study (Phase 2 and 3) and treatment arm, EPIC mean changes in subdomain scores over time will be compared, both for change from baseline and absolute health related quality of life scores.
Interventions
DRUGDEPO-ELIGARD 22
DRUG5 mg
DRUGTAXOTERE 160 mg/8 ml concentrate for solution for infusion.
DRUGDEPO-ELIGARD 7
DRUGDocetaxel AB 20 mg/ml concentraat voor oplossing voor infusie
DRUGZOLADEX
DRUG3
DRUG6 mg
DRUGimplant
DRUGDecapeptyl Sustained Release 3
DRUG75 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension
DRUGBAY 1841788
DRUG10
DRUG8 mg
Sponsors
Ziekenhuis Aan De Stroom
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 3 Intensification study: Incidence of ppMFS over time. PSMA PET metastatic progression is defined as the appearance of at least 1 new PSMA-PET-positive distant lesion compared with the baseline scan or date of death from any cause., Phase 2 De-intensification study: Health related Quality of Life (HRQL) will be reported by subjects using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. A clinically important point reduction in EPIC subdomain score is defined as follows: sexual (11 points), and hormonal (5 points) as detected at 12 months. EPIC scores will be measured on a yearly basis to monitor late effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS will be measured from the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, Prostate cancer-specific mortality (PCSM) will be measured from the date of randomization to the date of prostate cancer death., Biochemical progression-free survival will be measured from the date of randomization to the date event, or death or censored at the last known follow-up date. Events are PSA failure, castrate resistance (EAU Guidelines on Prostate Cancer 2022), receiving salvage therapy, or death from any cause., Time to next systemic therapy (NEST) will be measured from date of randomization to time of death, or censored at the last known follow-up date. Events for NEST are receiving any local therapy (surgery, radiotherapy, HIFU, cryotherapy) or systemic therapy for prostate cancer., Counts of all AEs by grade will be provided by study (Phase 2 and 3) and treatment arm, EPIC mean changes in subdomai | — |
Countries
Belgium, Spain
Outcome results
None listed