DEGARELIX for Metastatic prostate cancer|Prostate cancer

Inclusion criteria

• {"criterion_text":"-Age: 40 to 85 years old"}
• {"criterion_text":"-Language spoken: Finnish and Swedish"}
• {"criterion_text":"-Diagnosis: Histologically confirmed adenocarcinoma of prostate"}
• {"criterion_text":"-Adequate histological sampling consisting of at least 3 biopsy samples from each lobe"}
• {"criterion_text":"-No previous surgical, radiation or endocrine treatment for prostate carcinoma"}
• {"criterion_text":"-Clinical stage: T1c-T4NanyM1"}
• {"criterion_text":"-Serum creatinine ≤ 1,5 x ULN"}
• {"criterion_text":"-Mental status: Patients must be able to understand the meaning of the study"}
• {"criterion_text":"-Informed consent: The patient must sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff"}

Exclusion criteria

• {"criterion_text":"-Previous PC treatment"}
• {"criterion_text":"-Uncontrolled serious infection"}

Primary endpoints

• {"endpoint_text":"-To demonstrate that PSMA-flare seen 2-3weeks after initiation of ADT at baseline is more common in bony lesions than in prostatic lesions","definition_or_measurement_approach":"Assessed as PSMA-flare seen 2-3weeks after initiation of ADT (as stated in main objective)."}

Secondary endpoints

• {"endpoint_text":"-To study if metastatic lesions with and without PSMA-flare seen in baseline behave differently in repeated 18F-PSMA-PET CT at the time of CRPC","definition_or_measurement_approach":"Assessed with repeated 18F-PSMA-PET CT at the time of castration-resistant prostate cancer (as stated)."}
• {"endpoint_text":"-To compare the metastatic load seen in 18F-PSMA-PET CT and FDGPET- CT at baseline (Sub-study 1)","definition_or_measurement_approach":"Comparison of metastatic load on 18F-PSMA-PET CT versus FDG-PET-CT at baseline (as stated)."}
• {"endpoint_text":"-To determine the total androgen profile during the evolution of metastatic Pca by repeated total androgen measurements in every six months from diagnosis to the development of CRPC (Sub-study 2)","definition_or_measurement_approach":"Serial total androgen measurements performed every six months from diagnosis until development of CRPC (as stated)."}
• {"endpoint_text":"-To biopsy prostate lesions seen on 18F-PSMA PET and determine if the changes of PSMA uptake after ADT might have a histopathological correlation (Substudy 3)","definition_or_measurement_approach":"Biopsy of prostate lesions identified on 18F-PSMA PET and histopathological correlation with changes in PSMA uptake (as stated)."}
• {"endpoint_text":"-To investigate gut microbiome and its changes during ADT (Substudy 4)","definition_or_measurement_approach":"Analysis of gut microbiome composition and its changes during androgen deprivation therapy (as stated)."}

Finland

Earliest CTIS Part Ii Submission Date

27-01-2025

Latest Decision Or Authorization Date

28-01-2025

Processing Time Days

1

Number Of Sites

1

Number Of Participants

35

Primary sponsor

Full Name

Turku University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland