68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment
68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA
3 other identifiers
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 3, 2016
CompletedStudy Start
First participant enrolled
May 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2019
CompletedResults Posted
Study results publicly available
January 13, 2022
CompletedJanuary 13, 2022
January 1, 2022
11 months
February 1, 2016
September 1, 2021
January 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
68Ga-PSMA-11 PET/CT Sensitivity and Specificity
up to 12 months
68Ga-PSMA-11 PET/CT Predictive Value by Region
up to 12 months
Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
up to 12 months
Study Arms (1)
68Ga-PSMA-11 PET/CT
EXPERIMENTALPatients 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 .
Interventions
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).
68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrei Iagarulead
Study Sites (1)
Stanford University, School of Medicine
Palo Alto, California, 94304, United States
Related Publications (1)
Baratto L, Song H, Duan H, Hatami N, Bagshaw HP, Buyyounouski M, Hancock S, Shah S, Srinivas S, Swift P, Moradi F, Davidzon G, Iagaru A. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021 Nov;62(11):1545-1549. doi: 10.2967/jnumed.120.259630. Epub 2021 Mar 5.
PMID: 33674398DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrei Iagaru, Professor of Radiology (Nuclear Medicine)
- Organization
- Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Iagaru, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Radiology
Study Record Dates
First Submitted
February 1, 2016
First Posted
February 3, 2016
Study Start
May 20, 2017
Primary Completion
April 27, 2018
Study Completion
April 27, 2019
Last Updated
January 13, 2022
Results First Posted
January 13, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share