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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT04452136
Other study ID # STUDY00020072
Secondary ID STUDY00020073
Status Approved for marketing
Phase
First received
Last updated

Study information

Verified date March 2022
Source OHSU Knight Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
68GA PSMA-HBED-CC
Given IV

Locations

Country Name City State
United States OHSU Knight Cancer Institute Portland Oregon

Sponsors (4)

Lead Sponsor Collaborator
Jeanne Link OHSU Center of Radiochemistry Research, OHSU Knight Cancer Institute, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

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