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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02282137
Recruitment Status : Recruiting
First Posted : November 4, 2014
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Information provided by (Responsible Party):
Ebrahim Delpassand, Radio Isotope Therapy of America

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-PSMA Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer
Actual Study Start Date : May 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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 Name: 68Ga-HBED-CC-PSMA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282137


Contacts
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Contact: Susan Cork 713-781-6200 ext 3203 Scork@exceldiagnostics.com
Contact: Rodolfo Nunez, MD 713-781-6200 ext 3225 Rnunez@exceldiagnostics.com

Locations
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United States, Texas
Radio- Isotope Therapy of America Recruiting
Houston, Texas, United States, 77042
Contact: Susan Cork    713-341-3203    scork@exceldiagnostics.com   
Contact: Ayman Gaber, MBBCh-MS    713-781-6200 ext 3242    agaber@exceldiagnostics.com   
Principal Investigator: Rodolfo Nunez, MD         
Sub-Investigator: Ebrahim S Delpassand, MD-FACNM         
Sub-Investigator: Ayman Gaber, MBBCh-MS         
Sponsors and Collaborators
Ebrahim Delpassand
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Investigators
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Principal Investigator: Rodolfo Nunez, MD Excel Diagnostics and Nuclear Oncology Center
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Responsible Party: Ebrahim Delpassand, Chairman and Medical Director, Radio Isotope Therapy of America
ClinicalTrials.gov Identifier: NCT02282137    
Other Study ID Numbers: Ga PSMA124388
IND124388 ( Other Identifier: US Food and Drug Administration )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Keywords provided by Ebrahim Delpassand, Radio Isotope Therapy of America:
Prostate cancer
PET / CT
Ga-PSMA
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases