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

The effect of androgen deprivation therapy on the expression of prostate specific membrane antigen (PSMA) in treatment naive metastatic prostate cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004853-26-FI

Enrollment

Registered

2019-03-07

Start date

2019-03-25

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

Male

Inclusion 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-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

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

Design outcomes

Primary

Measure	Time frame
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);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 To study if metastatic lesions with and without PSMA-flare behave differently in contrast-enhanced whole body CT during the follow-up;Primary end point(s): comparison of mean increase in SUVmax in F-PSMA-PET between bony lesions and prostatic lesions after initiation of ADT;Timepoint(s) of evaluation of this end point: 2-3 weeks	—

Measure

Time frame

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);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 To study if metastatic lesions with and without PSMA-flare behave differently in contrast-enhanced whole body CT during the follow-up;Primary end point(s): comparison of mean increase in SUVmax in F-PSMA-PET between bony lesions and prostatic lesions after initiation of ADT;Timepoint(s) of evaluation of this end point: 2-3 weeks

—

Secondary

Measure	Time frame
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	—

Countries

Finland

Contacts

Public ContactPET Centre

Turku University Hospital

+35823130000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026