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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

68Ga-PSMA

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, PET / CT, Ga-PSMA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria

General requirements:

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

Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
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).
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.

Sites / Locations

Radio- Isotope Therapy of AmericaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-PSMA

Arm Description

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.

Outcomes

Primary Outcome Measures

The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.

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

Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value

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).

Full Information

NCT ID

NCT02282137

First Posted

October 27, 2014

Last Updated

August 17, 2020

Sponsor

Ebrahim Delpassand

Collaborators

Radiomedix, Inc., Excel Diagnostics and Nuclear Oncology Center

1. Study Identification

Unique Protocol Identification Number

NCT02282137

Brief Title

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

Acronym

PSMA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Recruiting

Study Start Date

May 2015 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ebrahim Delpassand

Collaborators

Radiomedix, Inc., Excel Diagnostics and Nuclear Oncology Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate cancer, PET / CT, Ga-PSMA

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

68Ga-PSMA

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

68Ga-PSMA

Other Intervention Name(s)

68Ga-HBED-CC-PSMA

Intervention Description

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.

Primary Outcome Measure Information:

Title

The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value

Description

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).

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria General requirements: Karnofsky performance status of ≥50 (or ECOG/WHO equivalent). Age > 18 years . Ability to understand a written informed consent document, and the willingness to sign it. 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). Post radical prostatectomy (RP) - AUA recommendation, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP. 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: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam. 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). 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Susan Cork

Phone

713-781-6200

Ext

3203

Scork@exceldiagnostics.com

First Name & Middle Initial & Last Name or Official Title & Degree

Rodolfo Nunez, MD

Phone

713-781-6200

Ext

3225

Rnunez@exceldiagnostics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodolfo Nunez, MD

Organizational Affiliation

Excel Diagnostics and Nuclear Oncology Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radio- Isotope Therapy of America

City

Houston

State/Province

Texas

ZIP/Postal Code

77042

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susan Cork

Phone

713-341-3203

scork@exceldiagnostics.com

First Name & Middle Initial & Last Name & Degree

Ayman Gaber, MBBCh-MS

Phone

713-781-6200

Ext

3242

agaber@exceldiagnostics.com

First Name & Middle Initial & Last Name & Degree

Rodolfo Nunez, MD

First Name & Middle Initial & Last Name & Degree

Ebrahim S Delpassand, MD-FACNM

First Name & Middle Initial & Last Name & Degree

Ayman Gaber, MBBCh-MS

12. IPD Sharing Statement

Learn more about this trial

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

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