68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/26/2018 |
| Start Date: | June 2016 |
| End Date: | June 2021 |
| Contact: | Risa Jiron |
| Email: | rjiron@stanford.edu |
| Phone: | 650-736-1598 |
68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
This phase II/III trial studies gallium 68 Ga (68Ga)-prostate-specific membrane antigen
(PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors in
patients with prostate cancer undergoing surgery that tend to spread quickly
(intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures,
such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease
has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have
specific receptors, and may allow doctors to see smaller tumors than the standard of care
contrast-enhanced computed tomography (CT) or MRI scan.
(PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors in
patients with prostate cancer undergoing surgery that tend to spread quickly
(intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures,
such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease
has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have
specific receptors, and may allow doctors to see smaller tumors than the standard of care
contrast-enhanced computed tomography (CT) or MRI scan.
PRIMARY OBJECTIVES:
I. Evaluate 68Ga-PSMA-11 PET/MRI for detection of regional nodal and distant metastases in
patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy
with lymph node dissection.
SECONDARY OBJECTIVES:
I. Sensitivity, specificity, positive and negative predictive value of 68Ga-PSMA-11 PET/MRI
for the detection of extra pelvic nodal metastases; visceral metastases; and osseous
metastases compared to biopsy and imaging follow up.
OUTLINE:
Patients receive 68Ga-PSMA intravenously (IV). Patients then undergo PET/MRI after 45 minutes
of administration of radiopharmaceutical injection.
After completion of study, patients are followed up at 24-48 hours.
I. Evaluate 68Ga-PSMA-11 PET/MRI for detection of regional nodal and distant metastases in
patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy
with lymph node dissection.
SECONDARY OBJECTIVES:
I. Sensitivity, specificity, positive and negative predictive value of 68Ga-PSMA-11 PET/MRI
for the detection of extra pelvic nodal metastases; visceral metastases; and osseous
metastases compared to biopsy and imaging follow up.
OUTLINE:
Patients receive 68Ga-PSMA intravenously (IV). Patients then undergo PET/MRI after 45 minutes
of administration of radiopharmaceutical injection.
After completion of study, patients are followed up at 24-48 hours.
Inclusion Criteria:
- Biopsy proven prostate adenocarcinoma
- Planned prostatectomy with lymph node dissection
- Intermediate to high risk disease (as determined by elevated PSA [PSA>10], T stage
[T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
- Able to provide written consent.
- Karnofsky performance status of ≥ 50 (or ECOG/WHO equivalent)
- Diagnostic CT or MRI performed within 90 days of the research PET
Exclusion Criteria:
- Patients not capable of getting PET study due to weight, claustrophobia, or inability
to lay still for the duration of the exam
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal
ablation techniques (HiFu)
- Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and
surgery
- Metallic implants (contraindicated for MRI)
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Andrei Iagaru
Phone: 650-736-1598
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