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

Prostate Adenocarcinoma Clinical Trial

Official title:

68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673151
• Other study ID #: IRB-35932
• Secondary ID: NCI-2016-00094PR
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 20, 2017
• Est. completion date: April 27, 2019

Study information

• Verified date: January 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 27, 2019
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• PSA Failure
• Recurrent Prostate Carcinoma

Intervention

Procedure:
• Computed Tomography (CT) scan
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Drug:
• 68Ga-PSMA-11
68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.

Procedure:
• Positron Emission Tomography (PET)
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Andrei Iagaru

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT	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.	up to 12 months
Secondary	68Ga-PSMA-11 PET/CT Sensitivity and Specificity	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.	up to 12 months
Secondary	68Ga-PSMA-11 PET/CT Predictive Value by Region	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.	up to 12 months
Secondary	Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level	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.	up to 12 months