68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer
Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer
2 other identifiers
interventional
937
1 country
1
Brief Summary
This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2018
CompletedFirst Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2021
CompletedSeptember 30, 2021
September 1, 2021
3.5 years
August 6, 2019
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
A separate analysis of initial versus subsequent management will be performed. Will be evaluated using descriptive statistics for both the treatment modality analysis and the disease stage based management analysis. Questionnaires will be collected to determine the intended patient management before and intended management changes after PET/CT, and to determine whether intended management changes were implemented. The outcome measure is the rate of change (%) as assessed by the questionnaires before and after PET.
Up to 3-6 months after completion of imaging
Secondary Outcomes (4)
Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS)
From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months
Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS
From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months
Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival
From inclusion to date of death, assessed up to 12 months
Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location
Up to 12 months
Study Arms (1)
Diagnostic (68Ga-PSMA-11 PET/CT)
EXPERIMENTALPatients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
Interventions
Undergo PET/CT
Given IV
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- Patients who fulfill criteria for initial staging or restaging as outlined below:
- Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (\> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:
- Surgery
- External radiation therapy (RT)
- Other focal therapies
- Systemic medical treatment
- Watchful waiting
- Assessment for subsequent treatment strategy (restaging), any of the following:
- Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:
- Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
- Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
- Patients with known prostate cancer who undergo restaging because of new symptoms
- Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
- Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
- Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
- +2 more criteria
You may not qualify if:
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
- Inability to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Related Publications (1)
Ma TM, Gafita A, Shabsovich D, Juarez J, Grogan TR, Thin P, Armstrong W, Sonni I, Nguyen K, Lok V, Reiter RE, Rettig MB, Steinberg ML, Kupelian PA, Yang DD, Muralidhar V, Chu C, Feng F, Savjani R, Deng J, Parikh NR, Nickols NG, Elashoff D, Czernin J, Calais J, Kishan AU. Identifying the Best Candidates for Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography as the Primary Staging Approach Among Men with High-risk Prostate Cancer and Negative Conventional Imaging. Eur Urol Oncol. 2022 Feb;5(1):100-103. doi: 10.1016/j.euo.2021.01.006. Epub 2021 Feb 16.
PMID: 33602654DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremie Calais
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 8, 2019
Study Start
April 2, 2018
Primary Completion
September 27, 2021
Study Completion
September 27, 2021
Last Updated
September 30, 2021
Record last verified: 2021-09