Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer
Primary Purpose
Prostatic Neoplasms, Prostatic Diseases, Prostate Cancer
Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
68GA PSMA-HBED-CC
Sponsored by
About this trial
This is an expanded access trial for Prostatic Neoplasms
Eligibility Criteria
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.
Sites / Locations
- OHSU Knight Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04452136
First Posted
June 25, 2020
Last Updated
March 11, 2022
Sponsor
Jeanne Link
Collaborators
OHSU Center of Radiochemistry Research, Oregon Health and Science University, OHSU Knight Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04452136
Brief Title
Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer
Official Title
68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeanne Link
Collaborators
OHSU Center of Radiochemistry Research, Oregon Health and Science University, OHSU Knight Cancer Institute
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostatic Diseases, Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
68GA PSMA-HBED-CC
Other Intervention Name(s)
68Ga-PSMA-11
Intervention Description
Given IV
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Mallak, M.D.
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer
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