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

Status: Active

Description

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

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Michael M. Graham
Phone: 319-356-1616
Email: michael-graham@uiowa.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

EXPLORATORY OBJECTIVES:

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.

OUTLINE:

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

Diagnostic

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
Clinicaltrials.gov ID NCT03388346