Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 9/21/2018 |
| Start Date: | March 2, 2018 |
| End Date: | March 2, 2020 |
Prospective Single Center Trial to Compare 68Ga-PSMA-11 and Axumin PET/CT (18F-Fluciclovine) for Restaging Prostate Cancer Patients With Biochemical Recurrence After Radical Prostatectomy
This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission
tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging
participants with prostate cancer after surgery that has come back. PET is an established
imaging technique that uses small amounts of radioactivity and CT images provide an exact
outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic
procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with
fluciclovine F18 in helping find out how far the prostate cancer has spread.
tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging
participants with prostate cancer after surgery that has come back. PET is an established
imaging technique that uses small amounts of radioactivity and CT images provide an exact
outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic
procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with
fluciclovine F18 in helping find out how far the prostate cancer has spread.
PRIMARY OBJECTIVES:
I. To compare the detection rates of gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) PET/CT and
fluciclovine F18 (Axumin) PET/CT for the identification of tumor location(s), by patient and
region based analysis.
SECONDARY OBJECTIVES:
I. Detection rate on a per-patient basis of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT,
stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5; 0.5 - < 1.0; 1.0 - < 2.0).
II. Sensitivity and positive predictive value (PPV) on a per-patient basis, of (68)Ga-PSMA-11
PET/CT and Axumin PET/CT for the detection of tumor location(s), confirmed by
histopathology/biopsy and/or clinical and conventional imaging follow-up.
III. Agreement among the readers, separate for (68)Ga-PSMA-11 PET/CT versus Axumin PET/CT.
OUTLINE:
Participants receive (68)Ga-PSMA-11 intravenously (IV) and 60-90 minutes later, undergo
PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT
within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
After completion of the PET/CT scan, participants are followed up between 1 and 3 days and up
to 12 months.
I. To compare the detection rates of gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) PET/CT and
fluciclovine F18 (Axumin) PET/CT for the identification of tumor location(s), by patient and
region based analysis.
SECONDARY OBJECTIVES:
I. Detection rate on a per-patient basis of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT,
stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5; 0.5 - < 1.0; 1.0 - < 2.0).
II. Sensitivity and positive predictive value (PPV) on a per-patient basis, of (68)Ga-PSMA-11
PET/CT and Axumin PET/CT for the detection of tumor location(s), confirmed by
histopathology/biopsy and/or clinical and conventional imaging follow-up.
III. Agreement among the readers, separate for (68)Ga-PSMA-11 PET/CT versus Axumin PET/CT.
OUTLINE:
Participants receive (68)Ga-PSMA-11 intravenously (IV) and 60-90 minutes later, undergo
PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT
within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
After completion of the PET/CT scan, participants are followed up between 1 and 3 days and up
to 12 months.
Inclusion Criteria:
- Histopathologically proven prostate cancer (PCa)
- Radical prostatectomy as definitive treatment for PCa
- Proven biochemical recurrence as defined by American Urological Association (AUA)
recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks
after radical prostatectomy
- PSA values ranging from 0.2 ng/mL to 2 ng/mL
- No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node
dissection)
- Axumin PET/CT scan already performed or scheduled as best standard of care procedure
for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11
PET/CT
- Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group
(ECOG)/World Health Organization [WHO] equivalent)
- Ability to understand a written informed consent document and the willingness to sign
it
Exclusion Criteria:
- Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan
- Unable to lie flat, still or tolerate a PET scan
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Johannes Czernin, M.D.
Phone: 310-206-7008
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