Status:
UNKNOWN
The Effect of ADT on PSMA-PET.
Lead Sponsor:
Turku University Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
NA
Brief Summary
Phase A: To describe and to determine the maximum standardised uptake values (SUV) in prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7, 14 and 28 days after ...
Detailed Description
Positron emission tomography has been commonly and successfully used, in combination with CT and MRI devices, in the staging of intermediate or high risk prostate cancer. Proper staging is essential t...
Eligibility Criteria
Inclusion
- Age: 40 to 85 years old
- Language spoken: Finnish
- Diagnosis: Histologically confirmed adenocarcinoma of prostate
- Adequate histological sampling consisting of at least 3 biopsy samples from each lobe
- No previous surgical, radiation or endocrine treatment for prostate carcinoma
- Clinical stage: T1c-T4N0-2M0-1 (arm, A); T1c-T3NxMx (arm, B)
- Serum creatinine ≤ 1,5 x ULN
- Patient agrees to undergo surgery (arm, B)
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion
- Infections: Patient must not have an uncontrolled serious infection
- contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- Prior usage of 5-ARI medication in past 12 months
- Patient preference for active surveillance as a method of prostate cancer management
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03313726
Start Date
September 20 2017
End Date
September 30 2018
Last Update
October 18 2017
Active Locations (1)
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1
Turku University Hospital
Turku, Finland, 20520