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

NCT04452136 | Unknown

• 2 other identifiers: STUDY00020072STUDY00020073
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; Prostatic Diseases; Prostate Cancer; Prostate Cancer Metastatic; Prostate Cancer Recurrent

Interventions

68GA PSMA-HBED-CC DRUG

Given IV

Also known as: 68Ga-PSMA-11

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nadine Mallak, M.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

US (1)