Phase 3
N=346
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03353740 ↗Enrolled (actual)
346
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ga-68 labeled PSMA-11 PET (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Thomas Hope
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up |
— | — |
| PRIMARY True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up |
— | — |
| PRIMARY True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up |
— | — |
| PRIMARY True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up |
— | — |
| SECONDARY Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. |
— | — |
| SECONDARY PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. |
— | — |
| SECONDARY PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. |
— | — |
| SECONDARY PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. |
— | — |
| SECONDARY True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only |
0.40 | — |
| SECONDARY True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only |
0.86 | — |
| SECONDARY True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only |
1.00 | — |
| SECONDARY True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only |
0.88 | — |
| SECONDARY PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only |
0.5 | — |
| SECONDARY PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only |
0.86 | — |
| SECONDARY PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only |
1.00 | — |
| SECONDARY PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only |
0.92 | — |
| SECONDARY Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value |
0.53; 0.68; 0.68; 0.93; 0.94 | — |
| SECONDARY Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment |
0.93; 0.65; 0.84 | — |
| SECONDARY Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) |
0.8; 0.8 | — |
| SECONDARY Percent of Participants With a Change in Clinical Management |
— | — |
| SECONDARY Rate of Inter-reader Reproducibility for Positivity |
— | — |
| SECONDARY Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events |
— | — |
Summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Eligibility Criteria
Inclusion Criteria
- Histopathologically proven prostate adenocarcinoma.
- Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy
- PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
- Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy
- Nadir + greater than or equal to 2 ng/mL rise in PSA
- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Age >= 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
- Unable to lie flat, still or tolerate a PET scan.
- Concomitant investigational therapy.
- Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Data sourced from ClinicalTrials.gov (NCT03353740). 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.