The effect of androgen deprivation therapy on prostate specific membrane antigen (PSMA)

Phase 1

• Conditions: Prostate cancer; MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002345-29-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-31
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 5

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 (Study APhase 1)
-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 (EC) 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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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

Study & Design

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