Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02673151 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT — 46; 15 Participants
◆ Published Evidence
Established
67citations · ~13 / year
PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer.
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.
Linked Publications
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PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.