Prostate cancer
Conditions
Brief summary
Disease-free survival 5 years after treatment. Disease recurrence is defined as PSA failure according to Phoenix, new lesions on PSMA PET and/or MRI imaging or the beginning of any salvage therapy.
Detailed description
Time to local or regional failure; after end of RT. Local or regional recurrences have to be confirmed by PSMA-PET or mpMR imaging. For the diagnosis of local failure, verification via biopsy is warranted., Metastatic free survival (MFS) after end of RT, (all metastases have to be confirmed by PSMA-PET/CT or mpMR imaging), Overall (OS) and prostate cancer specific (PCSS) survival after end of RT, Time to biochemical failure after end of RT (phoenix definition), Patient reported quality of life (QOL: EPIC-CP, IPSS and IIEF-5), Cumulative acute genitourinary (GU) and gastrointestinal (GI) toxicities during and up to 3 months after RT using the RTOG criteria, Cumulative chronic GU and GI toxicities after RT using the RTOG and CTCAEv5.0 criteria, Testosterone recovery
Interventions
DRUGGOSERELIN
Sponsors
Linac-Pet Scan Opco Limited
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival 5 years after treatment. Disease recurrence is defined as PSA failure according to Phoenix, new lesions on PSMA PET and/or MRI imaging or the beginning of any salvage therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to local or regional failure; after end of RT. Local or regional recurrences have to be confirmed by PSMA-PET or mpMR imaging. For the diagnosis of local failure, verification via biopsy is warranted., Metastatic free survival (MFS) after end of RT, (all metastases have to be confirmed by PSMA-PET/CT or mpMR imaging), Overall (OS) and prostate cancer specific (PCSS) survival after end of RT, Time to biochemical failure after end of RT (phoenix definition), Patient reported quality of life (QOL: EPIC-CP, IPSS and IIEF-5), Cumulative acute genitourinary (GU) and gastrointestinal (GI) toxicities during and up to 3 months after RT using the RTOG criteria, Cumulative chronic GU and GI toxicities after RT using the RTOG and CTCAEv5.0 criteria, Testosterone recovery | — |
Countries
Cyprus
Outcome results
None listed