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

Status:

APPROVED_FOR_MARKETING

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

Lead Sponsor:

Jeanne Link

Collaborating Sponsors:

OHSU Center of Radiochemistry Research

Oregon Health and Science University

Conditions:

Prostatic Neoplasms

Prostatic Diseases

Eligibility:

MALE

18+ years

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 w...

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 in...

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04452136

Last Update

March 14 2022

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