Defining Recurrent Disease With Axumin™

Status unconfirmed

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

This project seeks to use advanced imaging (specifically, positron emission tomography/computed tomography \[PET/CT\]) to detect, locate, and characterize recurrent disease in the setting of patients with prostate cancer.

Key facts

Study ID

NCT03996993

Run by

Cancer Center of Irvine

People needed

20

Starts

2019-07-01

Expected to finish

2020-12-30

Last updated by the study team

2019-06-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• General requirements:
• Karnofsky performance status of >50 (or ECOG/WHO equivalent).
• Age > 18.
• Ability to understand a written informed consent document, and the willingness to sign it.
• History of histologically confirmed adenocarcinoma of the prostate and underwent radical prostatectomy for primary treatment with curative intent.
• Men diagnosed with recurrent/persistent prostate cancer disease following radical prostatectomy based on a detectable or rising PSA value ≥ 0.1 ng/ml.
• Positive commercial standard of care (SOC) Axumin scan at time of restaging disease.
• Patients should not have been previously treated for biochemical recurrence (BCR) (i.e., this is the first diagnosis for BCR.
• Language proficiency in English, Spanish, Japanese, Korean, Vietnamese. Our office has translators to coherently translate the consent documents to patients.
• Inclusion criteria specific for patients on response to ADT study:
• Ability to tolerate androgen deprivation therapy (Casodex and Lupron) indefinitely.
• Been off ADT for minimum of 3 months.
• Ability to receive a possible of 4 Axumin PET/CT scans within a year.
• Inclusion criteria specific for patients on response to salvage radiotherapy study:
• Considering salvage radiotherapy.
• Ability to tolerate salvage radiation therapy for 8 weeks.

You may not qualify if…

• General requirements:
• Patients not capable of getting PET study due to weight, claustrophobia, allergic reaction, and/or inability to lay still for the duration of the exam.
• Women and children.
• Men currently on or seeking primary treatment (surgery or radiation) for prostate cancer.
• History of bilateral orchidectomy.
• Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. This includes focal ablation techniques (HiFu).
• Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist).
• 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.
• Exclusion criteria specific for patients on response to ADT study:
• Being considered for salvage radiotherapy.
• Androgen deprivation therapy (ADT) in the past 3 months.
• Exclusion criteria specific for patients on response to salvage radiotherapy study:
• Currently on ADT or on ADT within the past 3 months.

Where it is running

• Kenneth Tokita — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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