Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

Sponsor
Jeanne Link (Other)
Overall Status
Approved for marketing
CT.gov ID
NCT04452136
Collaborator
OHSU Center of Radiochemistry Research (Other), Oregon Health and Science University (Other), OHSU Knight Cancer Institute (Other)
1

Study Details

Study Description

Brief Summary

This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68GA PSMA-HBED-CC

Detailed Description

PRIMARY OBJECTIVE:

Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of potential metastatic or recurrent disease.

OUTLINE:

Eligible participants will be intravenously administered 68Ga PSMA-HBED-CC at a dose of 3-7 mCi (111 - 259 MBq), target 5 mCi. The estimated uptake time of the study agent is 75 minutes ± 25 minutes. The targeted uptake time is 60 minutes, with an acceptable range of 50-100 minutes. Following the PET scan with the study agent, participants will undergo either surgical management or treatment for metastatic disease in accordance with institutional standards.

Patients will be observed for 2 hours after injection of the radiotracer, and will be followed-up 1-3 days post injection with a phone call.

Study Design

Study Type:
Expanded Access
Official Title:
68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Inclusion Criteria:

    PLANNED PROSTATECTOMY

    • 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.

    • Planned prostatectomy with lymph node dissection

    • Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)

    BIOCHEMICAL RECURRENCE

    • Pathologically proven prostate adenocarcinoma. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    • If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (AUA recommendation for biochemical recurrence).

    • If post-radiation therapy, PSA that is equal to or greater than a 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence).

    • No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).

    ALL

    • Karnofsky performance status (KPS) >= 50 (ECOG/WHO 0, 1, or 2)

    • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations

    • Ability to understand and the willingness to provide informed consent

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OHSU Knight Cancer Institute Portland Oregon United States 97239

    Sponsors and Collaborators

    • Jeanne Link
    • OHSU Center of Radiochemistry Research
    • Oregon Health and Science University
    • OHSU Knight Cancer Institute

    Investigators

    • Principal Investigator: Nadine Mallak, M.D., OHSU Knight Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeanne Link, Professor, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT04452136
    Other Study ID Numbers:
    • STUDY00020072
    • STUDY00020073
    First Posted:
    Jun 30, 2020
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022

    Study Results

    No Results Posted as of Mar 14, 2022