The Effect of ADT on PSMA-PET. (ADTPSMA)

October 13, 2017 updated by: Turku University Hospital

The Effect of Androgen Deprivation Therapy on Prostate Specific Membrane Antigen (PSMA) in Prostate Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Positron emission tomography has been commonly and successfully used, in combination with CT and MRI devices, in the staging of intermediate or high risk prostate cancer. Proper staging is essential to guide the treatment options, which usually are radical prostatectomy or radiotherapy in localized prostate cancer or hormonal treatment in patients with metastasized disease, patients with hormonal relapse after radical radiotherapy or as an adjuvant treatment together with radiotherapy.

The use of PET imaging increases the sensitivity in the evaluation of lymph node involvement, as almost 80% of metastatic lymph nodes in prostate cancer are smaller than the threshold size usually measured with CT or MRI.

Nowadays new specific receptor targeted PET tracers in prostate cancer imaging has been introduced. One of the most used is 68Ga-PSMA that evaluates the expression of prostate-specific membrane antigen. This tracer has been rapidly taken into account for its better sensitivity and specificity in prostate cancer staging compared to the lipid metabolism tracers, like 11C/18F labeled fluorocholine or 11C-acetate.

In the recent literature it has been demonstrated for the first time on humans that PSMA expression, imaged with 68Ga-PSMA-11-PET, has increased in a patient with metastatic prostate cancer after androgen deprivation therapy (ADT).

These findings suggest that the use of hormonal therapy can affect the expression of PSMA and our hypothesis is that ADT therapy could increase the sensitivity of 68Ga-PSMA PET to detect nodal or distant metastasis in patients with prostate cancer. This prospective study consists in two phases. In phase A, 5 patients with newly diagnosed high risk prostate cancer with PSMA-positive nodal or distant metastasis screened by 68Ga-PSMA-11 PET/MRI, are given androgen deprivation therapy (ADT) with GNRH antagonist. After ADT therapy initiation, 68Ga-PSMA-11 PET/MRI is repeated at 7, 14 and 30 days to determine the highest PSMA expression based on SUVmax measurement.

In phase B, 20 high risk prostate cancer patients determined to undergo radical prostatectomy are screened with 68Ga-PSMA-11 PET/MRI, and then given GNRH antagonist therapy. 68Ga-PSMA-11 PET/MRI is repeated at the time of maximum PSMA expression based on phase A results. The patients then undergo radical prostatectomy and lymphadenectomy and imaging findings are matched with histological data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GnRh-antagonist A
Drug: GnRH antagonist
Administration of GnRh antagonist after baseline PSMA-PET at day 0 and then repeated PSMA-PET scans at day 7, day 14 and day 28 to define the timeframe of the SUV-max.
Drug: GnRH antagonist
Administration of GnRh-antagonist after baseline PSMA-PET at day 0 and then repeated scan at day in which SUV-max was observed in the Arm A (day 7, day 14 or day 28). Then robot assisted radical prostatectomy and lymphadenectomy are performed to verify the finding.
Experimental: GnRh-antagonist B
Drug: GnRH antagonist
Administration of GnRh antagonist after baseline PSMA-PET at day 0 and then repeated PSMA-PET scans at day 7, day 14 and day 28 to define the timeframe of the SUV-max.
Drug: GnRH antagonist
Administration of GnRh-antagonist after baseline PSMA-PET at day 0 and then repeated scan at day in which SUV-max was observed in the Arm A (day 7, day 14 or day 28). Then robot assisted radical prostatectomy and lymphadenectomy are performed to verify the finding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GnRh-antagonist, A
Time Frame: 0, 7, 14 and 28 days after ADT initiation
Maximum SUV in PSMA-PET
0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, B
Time Frame: 0 and 7, 14 or 28 days after ADT initiation according to phase A
Sensitivity and specificity of pre and post ADT 68Ga-PSMA-11 PET/MRI and standard clinical MRI using histology as a reference
0 and 7, 14 or 28 days after ADT initiation according to phase A

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GnRh-antagonist, A
Time Frame: 0, 7, 14 and 28 days after ADT initiation
Testosterone level (nmol/l)
0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, A
Time Frame: 0, 7, 14 and 28 days after ADT initiation
PSA level (ug/l)
0, 7, 14 and 28 days after ADT initiation
GnRh-antagonist, B
Time Frame: 56 and 112 days after ADT initiation
Testosterone level (nmol/l)
56 and 112 days after ADT initiation
GnRh-antagonist, B
Time Frame: 56 and 112 days after ADT initiation
EPIC-questionnaire total and hormonal score
56 and 112 days after ADT initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T83/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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