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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

About this trial

This is an expanded access trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)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.

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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