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 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT03553602
Eligibility Criteria:
Inclusion Criteria
* Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
* Initial cancer diagnosis that fits these specific criteria:
* Stages cT1-T3a
* Nx or N0
* Mx or M0
* Eligible initial definitive radiotherapy modalities include:
* External beam radiotherapy, with photon or proton beam therapy
* Definitive Brachytherapy
* Stereotactic Body Radiotherapy
* Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases
* Candidate for hormonal therapy.
* Current ECOG Performance status Scale 0-2 (Appendix D)
* Current International Prostate Symptom Score (IPSS) \< 20 (Appendix B)
* Age \>18
* The patient must be medically suitable to receive general or spinal anesthesia.
* AST, ALT, and alkaline phosphatase \< 2 x upper institutional limit within 3 months of registration.
* The patient must be able and willing to sign a study-specific written informed consent form before study entry.
Exclusion Criteria
* Preregistration radiation-related GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
* Treatment to a "whole pelvis" field with initial radiotherapy
* Patients with distant metastases (such as to the bone, visceral organs, and lymph nodes other than the pelvic nodes including the common iliac nodes).
* Patients receiving any other investigational agents.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
* Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03553602
Study Brief:
Protocol Section:
NCT03553602