68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

• Sponsor: Andrei Iagaru (Other)
• Overall Status: Completed
• CT.gov ID: NCT02673151
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.2
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

Condition or Disease	Intervention/Treatment	Phase
Prostate Adenocarcinoma; PSA Failure; Recurrent Prostate Carcinoma	Procedure: Computed Tomography (CT) scan; Drug: 68Ga-PSMA-11; Procedure: Positron Emission Tomography (PET)	Phase 2/Phase 3

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA
• Actual Study Start Date: May 20, 2017
• Actual Primary Completion Date: Apr 27, 2018
• Actual Study Completion Date: Apr 27, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 68Ga-PSMA-11 PET/CT Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .

Procedure: Computed Tomography (CT) scan; PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).; Other Names: Computerized Axial Tomography (CAT) CAT scan Computed Tomography (CT) Computerized Tomography (CT) CT Scan tomography ; Drug: 68Ga-PSMA-11; 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.; Other Names: 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11) 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC 68Ga-HBED-CC-PSMA HBED-CC-PSMA DFKZ-11 Heidelberg compound ; Procedure: Positron Emission Tomography (PET); PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).; Other Names: Positron Emission Tomography scan (PET-scan) Proton magnetic resonance spectroscopic imaging

Outcome Measures

Primary Outcome Measures

1. Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT [up to 12 months]

   Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.

Secondary Outcome Measures

1. 68Ga-PSMA-11 PET/CT Sensitivity and Specificity [up to 12 months]

   68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.

2. 68Ga-PSMA-11 PET/CT Predictive Value by Region [up to 12 months]

   Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.

3. Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level [up to 12 months]

   Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows. 0.2 to < 0.5 0.5 to < 1.0 1.0 to < 2.0 2.0 to < 5.0 ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histopathological proven prostate adenocarcinoma

• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

• Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation

• PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP

• Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)

• Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition

• A rise of PSA measurement of 2 or more ng/mL over the nadir

• Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group [ECOG] / World Health Organization [WHO] equivalent)

• Able to provide written consent

Exclusion Criteria:

• Investigational therapy for prostate cancer.

• Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University, School of Medicine	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Andrei Iagaru

Investigators

• Principal Investigator: Andrei Iagaru, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 12, 2018

More Information

Publications

None provided.

• Responsible Party: Andrei Iagaru, Professor of Radiology, Stanford University
• ClinicalTrials.gov Identifier: NCT02673151
• Other Study ID Numbers: IRB-35932; NCI-2016-00094; PROS0076
• First Posted: Feb 3, 2016
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Adenocarcinoma; Edetic Acid; Gallium 68 PSMA-11

Study Results

Participant Flow

Arm/Group Title	Diagnostic (68Ga-PSMA-11 PET/CT)
Arm/Group Description	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
Period Title: Overall Study
STARTED	61
COMPLETED	61
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Diagnostic (68Ga-PSMA-11 PET/CT)
Arm/Group Description	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
Overall Participants	61
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	51 83.6%
>=65 years	10 16.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.5 (6.7)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	61 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 9.8%
Not Hispanic or Latino	55 90.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	5 8.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	54 88.5%
More than one race	1 1.6%
Unknown or Not Reported	1 1.6%
Region of Enrollment (participants) [Number]
United States	61 100%

Outcome Measures

1. Primary Outcome

Title	Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT
Description	Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diagnostic (68Ga-PSMA-11 PET/CT)
Arm/Group Description	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
Measure Participants	61
Tumor-positive by 68Ga-PSMA-11 PET/CT	46 75.4%
Tumor-negative by 68Ga-PSMA-11 PET/CT	15 24.6%

2. Secondary Outcome

Title	68Ga-PSMA-11 PET/CT Sensitivity and Specificity
Description	68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diagnostic (68Ga-PSMA-11 PET/CT)
Arm/Group Description	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
Measure Participants	61
Sensitivity	100.0
Specificity	86.8

3. Secondary Outcome

Title	68Ga-PSMA-11 PET/CT Predictive Value by Region
Description	Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diagnostic (68Ga-PSMA-11 PET/CT)
Arm/Group Description	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
Measure Participants	61
Positive predictive value (PPV)	76.4
Negative predictive value (NPV)	100.0

4. Secondary Outcome

Title	Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
Description	Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows. 0.2 to < 0.5 0.5 to < 1.0 1.0 to < 2.0 2.0 to < 5.0 ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.2 to < 0.5 ng/m?	Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL	Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL	Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL	Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL
Arm/Group Description	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
Measure Participants	16	13	4	11	17
Positive predictive value (PPV)	31.3	75	100.0	82.1	84.7
Negative predictive value (NPV)	100.0	100.0	NA	100.0	100.0
Sensitivity	100.0	100.0	100.0	100.0	100.0
Specificity	91.4	88.9	NA	75.0	74.3

Adverse Events

Time Frame	3 days (per protocol).
Arm/Group Title	Diagnostic (68Ga-PSMA-11 PET/CT)
Arm/Group Description	Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same. 68Ga-PSMA-11: Given IV Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
All Cause Mortality
	Diagnostic (68Ga-PSMA-11 PET/CT)
	Affected / at Risk (%)	# Events
Total	0/61 (0%)
Serious Adverse Events
	Diagnostic (68Ga-PSMA-11 PET/CT)
	Affected / at Risk (%)	# Events
Total	0/61 (0%)
Other (Not Including Serious) Adverse Events
	Diagnostic (68Ga-PSMA-11 PET/CT)
	Affected / at Risk (%)	# Events
Total	0/61 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.