Gallium Ga 68-labeled PSMA-11 PET / CT in Diagnosing Participants with Intermediate to High-Risk Prostate Cancer

Status: Active


This pilot phase II / III trial studies how well gallium Ga 68-labeled PSMA-11 positron emission tomography / computed tomography (PET / CT) works in diagnosing participants with intermediate to high-risk prostate cancer. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / CT, may help detect pelvic nodal disease in participants with prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Biopsy-proven prostate adenocarcinoma
  • Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater
  • A PSA level result within the last 2 months
  • Planned prostatectomy with lymph node dissection
  • Karnofsky performance status (KPS) >= 50 (Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] 0, 1, or 2) within the last 3 months
  • Must be treatment naive (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., high intensity focused ultrasound [HiFu])
  • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an investigational new drug (IND) for initial efficacy investigations
  • Ability to understand and the willingness to provide informed consent

Exclusion Criteria

  • Cannot receive furosemide
  • Allergy to sulfa or sulfa-containing medications
  • History of Stevens-Johnson syndrome
  • Known Paget’s disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Locations & Contacts


Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Michael M. Graham
Phone: 319-356-1616

Trial Objectives and Outline


I. Determine sensitivity, specificity, positive, and negative predictive value of gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga PSMA-HBED-CC) PET for detection of regional pelvic nodal metastases compared to pathology at radical prostatectomy (per patient, using nodal regional correlation).


I. Determine sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA-HBED-CC PET for detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases compared to biopsy and imaging follow-up.


I. Determine sensitivity, specificity, positive, and negative predictive value for detection of regional nodal metastases in comparison to cross-sectional imaging performed contemporaneously with 68Ga PSMA-HBED-CC PET.

II. Compare progression free survival at one year (as measured by prostate specific antigen [PSA]) between patients with, and without, nodal metastases.

III. Correlate maximum standardized uptake value (SUVmax) from 68Ga PSMA-HBED-CC PET and short-axis diameter (of nodal disease on cross-sectional imaging) to presence of true pathology.

IV. Quantify and describe the incidence of osseous and distant metastatic lesions.


Participants receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and 75 minutes later undergo PET/CT over 25 to 40 minutes. Participants with disease outside the pelvic region and no clinical imaging obtained as standard of care after the first scan may receive a second dose of gallium Ga 68-labeled PSMA-11 and undergo a second PET/CT.

After completion of study treatment, participants are followed up at 1 day and then up to 12 months.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type


Lead Organization

Lead Organization
University of Iowa / Holden Comprehensive Cancer Center

Principal Investigator
Michael M. Graham

Trial IDs

Primary ID 201708824
Secondary IDs NCI-2018-00418 ID NCT03388346