Phase 3
N=61
68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment
Prostate Adenocarcinoma · PSA Failure · Recurrent Prostate Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02673151 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT — 46; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Computed Tomography (CT) scan (Procedure); 68Ga-PSMA-11 (Drug); Positron Emission Tomography (PET) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Andrei Iagaru
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT |
46; 15 | — |
| SECONDARY 68Ga-PSMA-11 PET/CT Sensitivity and Specificity |
100.0; 86.8 | — |
| SECONDARY 68Ga-PSMA-11 PET/CT Predictive Value by Region |
76.4; 100.0 | — |
| SECONDARY Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level |
31.3; 75; 100.0; 82.1; 84.7; 100.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02673151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.