The effect of androgen deprivation therapy on the expression of prostate specific membrane antige

Phase 1

• Conditions: Metastatic prostate cancer; MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10071119 Term: Hormone-dependent prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004853-26-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 35

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-T4NanyM1
-Serum creatinine = 1,5 x ULN
-Mental status: Patients must be able to understand the meaning of the study
-Informed consent: The patient must sign the appropriate Ethical Committee approved informed consent documents in the presence of the
designated staff

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-Previous PC treatment
-Uncontrolled serious infection
-Prior usage of 5-ARI medication in past 12 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate flare in PSMA expression 2-3 weeks after initiation of androgen deprivation therapy in metastatic lesions as seen in previous clinical trial (clinicaltrials.gov identifier: NCT03313726);Timepoint(s) of evaluation of this end point: 2-3 weeks;<br> Secondary Objective: To study if metastatic lesions with and without PSMA-flare behave differently in repeated 18F-PSMA PET-CT at the time of CRPC<br><br> To study if metastatic lesions with and without PSMA-flare behave differently in contrast-enhanced whole body CT during the follow-up<br> ;Primary end point(s): comparison of mean increase in SUVmax in F-PSMA-PET between bony lesions and prostatic lesions after initiation of ADT

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): to classify metastatic lesions into those with PSMA-flare and those without and then determine their potential to progress during the follow-up until CRPC;Timepoint(s) of evaluation of this end point: 3 years