The Effect of ADT on PSMA-PET.

• Status: Unknown status
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: Male

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 ADT.

Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is done before ADT and at maximum SUV defined by the phase A.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Treatments: Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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