Phase 2
N=1,435
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Prostate Cancer · Prostate Adenocarcinoma · Prostate Cancer Metastatic · Prostate Cancer Recurrent
Bottom Line
View on ClinicalTrials.gov: NCT03396874 ↗Enrolled (actual)
1,435
Serious AEs
0.1%
Results posted
Nov 2023
Primary outcome: Primary: Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology. — 87.3 percentage of times value is true — p=<0.0000001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 68Ga-PSMA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Michigan
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology. |
87.3 | <0.0000001 sig |
| SECONDARY Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. |
92.3; 95.29; 91.1; 91.72; 90.78; 96.97 | <0.0000001 sig |
| SECONDARY Adverse Events of 68Ga-PSMA Administration |
1; 2 | — |
| SECONDARY Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT |
55.1; 71.2; 85.5; 91.1; 95.4 | — |
| SECONDARY Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients |
886; 374; 294; 594; 1; 213 | — |
Summary
This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.
To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.
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) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
- Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
- Karnofsky performance status of ≥ 50.
- Age ≥ 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- Current investigational therapy for prostate cancer.
- Unable to lie flat, still or tolerate a PET/CT scan.
- Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
- Prisoner.
Data sourced from ClinicalTrials.gov (NCT03396874). 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.