Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03996993
Eligibility Criteria:
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.
Exclusion criteria specific for patients on response to ADT study:
1. Being considered for salvage radiotherapy.
2. Androgen deprivation therapy (ADT) in the past 3 months.
Exclusion criteria specific for patients on response to salvage radiotherapy study:
1\. Currently on ADT or on ADT within the past 3 months.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03996993
Study Brief:
Protocol Section:
NCT03996993