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Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients (PSMA PET)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ga-68 labeled HBED-CC PSMA

Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)

Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:
- Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15 ng/mL and/or Gleason score ≥ 4+4.
- Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months.
  i. These patients may have received androgen deprivation therapy prior to imaging.
- Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).
  i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment
Age > 18.
Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

High-risk prostate cancer pre-prostatectomy (preRP) population

Biochemical Recurrence (BCR)

Castrate Resistant Prostate cancer (CRCP) population

Arm Description

Patients with high-risk prostate cancer pre-prostatectomy. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Patients with prostate cancer with biochemical recurrence Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Patients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Outcomes

Primary Outcome Measures

Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.

Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.

Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.

Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.

Secondary Outcome Measures

Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group

68Ga-labeled prostate-specific membrane antigen 11 (Ga68-PSMA-11) PET positivity rate by prostate-specific antigen (PSA) level is calculated by the number of positive reads divided by the total number of patients in the BCR Group per PSA value quintile (Detection rate (d) = total number of positive reads (t)/ total number of participants (N)).

Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management

Change in participant medical management was determined based on the results of surveys given to each participant's treating physician. Results of the survey were categorized as a major change in participant's medical management, a minor change in participant's medical management, no change to participant's medical management, or change to participant's medical management is unknown. These categories were developed based on a predetermined categorization schema.

Full Information

NCT ID

NCT02611882

First Posted

September 29, 2015

Last Updated

November 26, 2020

Sponsor

Thomas Hope

1. Study Identification

Unique Protocol Identification Number

NCT02611882

Brief Title

Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients

Acronym

PSMA PET

Official Title

Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

December 18, 2015 (Actual)

Primary Completion Date

October 24, 2016 (Actual)

Study Completion Date

October 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Hope

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.

Detailed Description

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become available for clinical imaging in prostate cancer patients. This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring HBED-CC PSMA to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval. This study focuses on three patients populations that are imaged. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. In the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. In the castrate resistant prostate cancer population the primary objective is to determine if PSMA PET detects more metastatic lesions than conventional imaging.

6. Conditions and Keywords

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

Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-risk prostate cancer pre-prostatectomy (preRP) population

Arm Type

Experimental

Arm Description

Patients with high-risk prostate cancer pre-prostatectomy. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Arm Title

Biochemical Recurrence (BCR)

Arm Type

Experimental

Arm Description

Patients with prostate cancer with biochemical recurrence Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Arm Title

Castrate Resistant Prostate cancer (CRCP) population

Arm Type

Experimental

Arm Description

Patients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Intervention Type

Drug

Intervention Name(s)

Ga-68 labeled HBED-CC PSMA

Other Intervention Name(s)

Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, Ga-68 labeled Glu-urea-Lys(Ahx)-HBED-CC

Intervention Description

The imaging agent (Ga-68 HBED-CC PSMA) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET/CT imaging. The one-time nominal injected dose will be 3 to 7 millicurie (mCi) containing 10 - 25 μg Ga-68 HBED-CC PSMA.

Intervention Type

Device

Intervention Name(s)

Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)

Other Intervention Name(s)

PET/CT

Intervention Description

Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/CT scan includes two parts: a PET scan and a CT scan. The CT portion of the scan produces a 3-D image that shows a patient's anatomy. The PET scan demonstrates function and what's occurring on a cellular level. The PET scan is unique because it images the radiation emitted from the patient while the CT records anatomical x-rays, showing the same area from another perspective

Intervention Type

Device

Intervention Name(s)

Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)

Other Intervention Name(s)

PET/MRI

Intervention Description

Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Coverage for the scan will extend from the patients vertex through the mid thighs. We will use 4 minute acquisitions per bed position for PET imaging.

Primary Outcome Measure Information:

Title

Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases

Description

Time Frame

1 day

Title

Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis

Description

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.

Time Frame

1 day

Title

Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis

Description

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.

Time Frame

1 day

Title

Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis

Description

Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.

Time Frame

one month

Secondary Outcome Measure Information:

Title

Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group

Description

Time Frame

Up to 1 year

Title

Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management

Description

Time Frame

Up to 1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below: Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15 ng/mL and/or Gleason score ≥ 4+4. Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months. i. These patients may have received androgen deprivation therapy prior to imaging. Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27). i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment Age > 18. Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent). Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Hope

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31039025

Citation

Lawhn-Heath C, Flavell RR, Behr SC, Yohannan T, Greene KL, Feng F, Carroll PR, Hope TA. Single-Center Prospective Evaluation of 68Ga-PSMA-11 PET in Biochemical Recurrence of Prostate Cancer. AJR Am J Roentgenol. 2019 Aug;213(2):266-274. doi: 10.2214/AJR.18.20699. Epub 2019 Apr 30.

Results Reference

result

PubMed Identifier

34529005

Citation

Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.

Results Reference

derived

PubMed Identifier

28522741

Citation

Hope TA, Aggarwal R, Chee B, Tao D, Greene KL, Cooperberg MR, Feng F, Chang A, Ryan CJ, Small EJ, Carroll PR. Impact of 68Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2017 Dec;58(12):1956-1961. doi: 10.2967/jnumed.117.192476. Epub 2017 May 18.

Results Reference

derived

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Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients

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