68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrei Iagaru
• Collaborator: National Cancer Institute (NCI)
• Treatments: Edetic Acid; N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid

Criteria

Inclusion Criteria:

• Histopathological proven prostate adenocarcinoma

• Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

• Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation

• PSA greater than 0.2 ng/mL measured 6-13 weeks after RP

• Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)

• Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition

• A rise of PSA measurement of 2 or more ng/mL over the nadir

• Able to provide written consent

• Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

Exclusion Criteria:

• Investigational therapy for prostate cancer.

• Unable to lie flat, still or tolerate a PET scan.

• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.