Diagnosing and Monitoring Recurrent Disease in Prostate Cancer Patients Using a Positron Emission Tomography Radiotracer (Axumin™)

Condition: Prostate Cancer, Prostate Adenocarcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03996993

Sponsor: Cancer Center of Irvine

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. General requirements:
2. Karnofsky performance status of >50 (or ECOG/WHO equivalent).
3. Age >
4. Ability to understand a written informed consent document, and the willingness to sign it.
5. History of histologically confirmed adenocarcinoma of the prostate and underwent radical prostatectomy for primary treatment with curative intent.
6. Men diagnosed with recurrent/persistent prostate cancer disease following radical prostatectomy based on a detectable or rising PSA value ≥ 0.1 ng/ml.
7. Positive commercial standard of care (SOC) Axumin scan at time of restaging disease.
8. Patients should not have been previously treated for biochemical recurrence (BCR) (i.e., this is the first diagnosis for BCR.
9. 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:
10. Ability to tolerate androgen deprivation therapy (Casodex and Lupron) indefinitely.
11. Been off ADT for minimum of 3 months.
12. 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:
13. Considering salvage radiotherapy.
14. Ability to tolerate salvage radiation therapy for 8 weeks. Exclusion Criteria: General requirements:
15. 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.
16. Women and children.
17. Men currently on or seeking primary treatment (surgery or radiation) for prostate cancer.
18. History of bilateral orchidectomy.
19. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. This includes focal ablation techniques (HiFu).
20. Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist).
21. 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:
22. Being considered for salvage radiotherapy.
23. Androgen deprivation therapy (ADT) in the past 3 months.

Exclusion Criteria:

1. General requirements:
2. 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.
3. Women and children.
4. Men currently on or seeking primary treatment (surgery or radiation) for prostate cancer.
5. History of bilateral orchidectomy.
6. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. This includes focal ablation techniques (HiFu).
7. Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist).
8. 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:
9. Being considered for salvage radiotherapy.
10. Androgen deprivation therapy (ADT) in the past 3 months. Exclusion criteria specific for patients on response to salvage radiotherapy study:
11. Currently on ADT or on ADT within the past 3 months.

View trial on ClinicalTrials.gov