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ADTPSMA2: The Effect of ADT on PSMA Expression in Metastatic Prostate Cancer

Sponsor
Turku University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03876912
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Thirty-five men with newly diagnosed, metastatic prostate cancer are scanned with 18F-PSMA 1007 PET/CT at baseline, 3 weeks after the initiation of GnRH-antagonist, at one year and at the time of castration resistant prostate cancer (CRPC). The aim of the study is to classify metastatic lesions into those with PSMA-flare and those without and determine their potential to progress during the follow-up until CRPC.

Condition or Disease Intervention/Treatment Phase
  • Drug: GnRH antagonist
 N/A

Detailed Description

In metastatic prostate cancer androgen deprivation therapy (ADT) has been traditionally used as a first line approach. Based on histological studies, animal models and PSMA-PET imaging, it is known that administration of ADT increases prostate specific membrane antigen (PSMA) expression.

Preliminary results of our previous prospective clinical trial (clinicaltrials.gov identifier: NCT03313726) with nine men demonstrated a heterogenous flare in PSMA expression 2-3 weeks after ADT, more evidently in bone metastases. Our hypothesis is that metastatic lesions having PSMA-flare respond differently to ADT and have different outcome than those without PSMA-flare. Therefore, the objective of the study is to demonstrate the PSMA-flare seen in bone lesions 3 weeks after ADT and then determine the potential predictive value of the phenomenon in the progression to castration resistant prostate cancer (CRPC).

Thirty-five men with newly diagnosed, metastatic PC will undergo 18F-PSMA 1007 PET/CT before and 3 weeks after the initiation of sub-cutaneous injection of GnRH-antagonist (Degarelix, Firmagon®). A subgroup of 20 patients will receive an additional FDG PET/CT scan before ADT to investigate whether lesions with PSMA flare show a different metabolic behaviour on FDG PET. During the follow-up, 18F-PSMA 1007 PET/CT will be also performed once a year. Finally all patients will repeat 18F-PSMA 1007 PET/CT at the time of CRPC. In addition to imaging, PSA is measured, and blood drawn for androgen levels and biomarkers in three months interval.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Androgen Deprivation Therapy on the Expression of Prostate Specific Membrane Antigen (PSMA) Evaluated With 18F-PSMA PET/CT in Treatment naïve Metastatic Prostate Cancer Patients
Actual Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: GnRH antagonist

Administration of GnRH antagonist (subcutaneous injection, 240 mg) after baseline 18F-PSMA 1007 PET/CT.Then 18F-PSMA 1007 PET/CT is repeated 3 weeks after ADT and at development of CRPC

Drug: GnRH antagonist
18F-PSMA 1007 PET/CT before, 3 weeks after ADT, at 1 year and at CRPC in 35 patients. 18F-FDG PET/CT in a subgroup of 20 patients before ADT.
Other Names:
  • Degarelix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PSMA-flare after ADT [2-3 weeks]

      Comparison of mean increase of SUVmax in 18F-PSMA 1007 PET between bone lesions and prostatic lesions after the initiation of ADT

    Secondary Outcome Measures

    1. PSMA-flare in the follow-up until CRPC [2-3 years]

      Compare SUVmax of lesions with PSMA flare and those without during the follow-up and at CRPC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Exclusion Criteria:

    • Previous PC treatment

    • Uncontrolled serious infection

    • Prior usage of 5-ARI medication in past 12 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku University Hospital Turku Finland 20500

    Sponsors and Collaborators

    • Turku University Hospital

    Investigators

    • Principal Investigator: Jukka Kemppainen, Adj.Prof., Turku University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT03876912
    Other Study ID Numbers:
    • ADTPSMA2
    First Posted:
    Mar 15, 2019
    Last Update Posted:
    Apr 13, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Turku University Hospital
    Prostate Specific Membrane Antigen
    GnRH antagonist
    Positron Emission Tomography
    PSMA-PET/CT
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Apr 13, 2021