Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging

NCT04348682 | Unknown

• 1 other identifier: 19-001868
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To provide expanded access to 68Ga-PSMA-11 PET imaging for eligible participants to detect and localize prostate cancer for initial and subsequent treatment strategy.

Conditions

Prostate Cancer

Keywords

prostate; imaging

Interventions

Positron Emission Tomography (PET) Imaging DIAGNOSTIC_TEST

A single dose activity of 5 mCi (accepted range of 3-7 mCi) of 68Ga-PSMA-11 will be intravenously administered to patient as a bolus injection. After 50-100 minutes of uptake time, the patient will undergo a whole body (skull to mid-thighs) PET/CT imaging.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participation is not based on self-representation. Participation is based on the possession of a prostate gland.
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathological proven prostate adenocarcinoma.
• Rising prostatic specific antigen(PSA) after definitive therapy with prostatectomy or radiation therapy.
• Post radical prostatectomy (RP)
• PSA equals to or greater than 0.2 ng/mL measured more than 6weeks after RP
• Post-radiation therapy -ASTRO-Phoenix consensus definition
• 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.

You may not qualify if:

• Concomitant investigational therapy.
• Known inability to lie flat, remain still or tolerate a PET scan.
• 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.
• Preprostatectomy Staging Population:
• Biopsy proven prostate adenocarcinoma.
• Considered for 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).
• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
• Neoadjuvant chemotherapy, radiation therapy or any definitive local therapy prior to prostatectomy including focal ablation techniques (HiFu).

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Jeremie Calais, M.D.

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: April 16, 2020
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

US (1)