High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

July 1, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.

Study Overview

Status

Status

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

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

Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.

The study consists of 2 work units (WU):

Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent

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 (Estimated)

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.
188

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 Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

Work-unit 1

  • age < 75 years of age, with histologically proven invasive adenocarcinoma of the prostate
  • a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
  • scheduled to undergo radical prostatectomy with extended lymph node dissection

Work-unit 2

  • histologically proven diagnosis of prostate cancer
  • biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment
  • WHO performance state 0-1
  • age > 18 years old

Exclusion criteria

Work-unit 1

  • involvement of pelvic lymph nodes assessed by multi-parametric MRI
  • evidence for bone metastasis assessed by bone scan (if PSA > 20 ng/ml)
  • WHO performance status > 2
  • previous pelvic irradiation or radical prostatectomy.
  • other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years
  • any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Work-unit 2

  • serum testosterone level <50ng/ml
  • symptomatic metastases
  • local relapse on MRI
  • PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy
  • previous treatment with cytotoxic agent for PCa
  • treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
  • disorder precluding understanding of trial information or informed consent

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: N/A
  • Interventional Model: Single Group 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: 68Ga-PSMA PET/MR
Hybrid 68Ga-PSMA PET/MR scan
Other: 68Ga-PSMA (HBED-CC) PET
68Ga-PSMA PET/MR

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
68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.
Time Frame: through study completion, an average of 2 year
Assessment of the sensitivity, specificity, positive and negative predictive
through study completion, an average of 2 year

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
The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.
Time Frame: through study completion, an average of 2 year
Correlation between tracer uptake and pathology Gleason score
through study completion, an average of 2 year
Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.
Time Frame: through study completion, an average of 2 year
Assessment of the sensitivity, specificity, positive and negative predictive value
through study completion, an average of 2 year
The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.
Time Frame: through study completion, an average of 2 year
Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI
through study completion, an average of 2 year

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.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karolien Goffin, MD, PhD, UZ Leuven

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 22, 2017

Primary Completion (Estimated)

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.
December 1, 2025

Study Completion (Estimated)

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.
December 1, 2025

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).
July 10, 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 30, 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 31, 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.
July 3, 2024

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.
July 1, 2024

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.
July 1, 2024

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.
  • S59428
  • 2016-003089-14 (EudraCT Number)

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.

Clinical Trials on Prostate Cancer

Clinical Trials on 68Ga-PSMA (HBED-CC) PET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings