68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer (PSMA)

August 17, 2020 updated by: Ebrahim Delpassand

68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer

This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (PSMA) on their surface. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA-11 PET / CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body.

A 68Ga-PSMA-11 PET / CT scan may help doctors to better detect the location, extent, and characteristics of the tumor, allowing improved planning of subsequent therapy

Study Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Phase 2

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 Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77042
        • Recruiting
        • Radio- Isotope Therapy of America
        • Contact:
        • Principal Investigator:
          • Rodolfo Nunez, MD
        • Contact:
        • Sub-Investigator:
          • Ebrahim S Delpassand, MD-FACNM
        • Sub-Investigator:
          • Ayman Gaber, MBBCh-MS

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

General requirements:

  1. Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).
  2. Age > 18 years .
  3. Ability to understand a written informed consent document, and the willingness to sign it.

  4. i. inclusion criteria specific for the pre-prostatectomy group:

    • Biopsy proven prostate adenocarcinoma.
    • Planned prostatectomy with lymph node dissection.
    • Intermediate to high-risk disease (as determined by elevated PSA [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).

4. ii. inclusion criteria specific for biochemical recurrence group:

  • Histopathological proven prostate adenocarcinoma.

  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    1. Post radical prostatectomy (RP) - AUA recommendation, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
    2. Post-radiation therapy -ASTRO-Phoenix consensus definition, Nadir + greater than or equal to 2 ng/mL rise in PSA 5. Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET

Exclusion Criteria

General requirements:

  1. Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
  2. Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criterion can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
  3. i. Exclusion criteria specific for the pre-prostatectomy group: Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu) within the last 2 months.

3. ii. Exclusion criteria specific for biochemical recurrence group:

  • Investigational therapy for prostate cancer for less than 2 months.
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

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
Intervention / Treatment
Experimental: 68Ga-PSMA
Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.
Drug: 68Ga-PSMA
Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
Other Names:
  • 68Ga-HBED-CC-PSMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.
Time Frame: 12 months
The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value
Time Frame: 12 months
Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value (0.2 - <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, 5.0).
12 months

Collaborators and Investigators

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

Sponsor

Ebrahim Delpassand

Collaborators

Excel Diagnostics and Nuclear Oncology Center
Radiomedix, Inc.

Investigators

  • Principal Investigator: Rodolfo Nunez, MD, Excel Diagnostics and Nuclear Oncology Center

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)

May 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ga PSMA124388
  • IND124388 (Other Identifier: US Food and Drug Administration)

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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