Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
prostate cancer, Axumin
Brief summary
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.
Detailed description
This protocol details the study design for patients with prostate cancer (PCa) who have failed primary treatment with radical prostatectomy, and now have rising PSA as indicated by a recent PSA blood draw value \> 0.1 ng/ml. Patients fitting our inclusion criteria for the study, will receive an Axumin scan as part of their standard of care (SOC) treatment. If the SOC scan is positive, patients under this protocol will either subsequently receive hormone therapy OR salvage radiation therapy (not both concurrently). Patient response to therapy will be assessed with serial Axumin scans identifying additional lesions present at 3 months, 6 months, and 12 months (1 year) post-therapy, with the latter time point being our endpoint of the study. The study aims are as follows: 1. The investigators would like to understand the hormonal therapy response based on Axumin scans administered over a time course of 3 months, 6 months, and 12 months post-hormone therapy treatment. 2. The investigators would like to understand the salvage radiotherapy response based on Axumin scan results incorporated into radiation treatment planning over a time course of 3 months, 6 months, and 12 months post-salvage radiation treatment.
Interventions
DRUGCasodex, Axumin
Patients will receive hormone therapy if Axumin positive area appears.
RADIATIONSalvage Radiation, Axumin
Patients will receive salvage radiation therapy if Axumin positive area appears.
Sponsors
Cancer Center of Irvine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
General requirements: 1. Karnofsky performance status of \>50 (or ECOG/WHO equivalent). 2. Age \> 18. 3. Ability to understand a written informed consent document, and the willingness to sign it. 4. History of histologically confirmed adenocarcinoma of the prostate and underwent radical prostatectomy for primary treatment with curative intent. 5. Men diagnosed with recurrent/persistent prostate cancer disease following radical prostatectomy based on a detectable or rising PSA value ≥ 0.1 ng/ml. 6. Positive commercial standard of care (SOC) Axumin scan at time of restaging disease. 7. Patients should not have been previously treated for biochemical recurrence (BCR) (i.e., this is the first diagnosis for BCR. 8. 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: 1. Ability to tolerate androgen deprivation therapy (Casodex and Lupron) indefinitely. 2. Been off ADT for minimum of 3 months. 3. 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: 1. Considering salvage radiotherapy. 2. Ability to tolerate salvage radiation therapy for 8 weeks.
Exclusion criteria
General requirements: 1. 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. 2. Women and children. 3. Men currently on or seeking primary treatment (surgery or radiation) for prostate cancer. 4. History of bilateral orchidectomy. 5. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. This includes focal ablation techniques (HiFu). 6. Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist). 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of baseline Axumin uptake | 2019-2020 | Utilizing standard uptake values (SUV) from the tumor origin, serial Axumin SUV values will be calculated as a percentage of the baseline SUV value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA blood draw | 2019-2020 | Prostate specific antigen (PSA) values expressed as \[ng/ml\] will be serially drawn at each time of the Axumin scan to correlate with percentage of baseline SUV value. |
Countries
United States
Outcome results
None listed