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:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT03860961
Eligibility Criteria:
Inclusion Criteria:
* PRACTICE ELIGIBILITY CRITERIA
* All institutions participating in a practice are NCORP components or sub-components
* Have a mechanism for delivering SCPs to prostate cancer patients. Practices that currently provide SCPs are eligible but for this trial will need to use the study-provided SCP template.
* See at least 10 patients meeting eligibility criteria per year.
* Completion and submission of the NRG-CC007CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit \[CTSU\] website) by each practice to NRGCC007CD@nrgoncology.org).
* Institutional Review Board (IRB) approval
* Each principal investigator (PI) and research assistant (RA) at a NCORP practice must complete NRG-CC007CD SCP training. A training certificate will need to be completed and uploaded to the CTSU Regulatory Submission Portal. (See NRG-CC007CD Training Memo and Slides; located on the CTSU website). Note: staff and physicians cannot be part of multiple practices
* For a practice that is participating on Wake Forest study, WF-1804CD is not able to participate in this trial in order to not impact the fidelity of either trial. As long as the clinicians (physicians, American Physician Partners \[APPs\]) are different for the patient populations of the two trials, a practice is eligible to participate in both trials
* PATIENT ELIGIBILITY CRITERIA - PRIOR TO REGISTRATION (STEP 1)
* The participant must be able to complete required questionnaires in English
* The participant must have a diagnosis of prostate adenocarcinoma that will be treated with RT plus androgen deprivation therapy (ADT) with curative intent. Both definitive RT (intact prostate) and postprostatectomy RT patients are eligible
* The ADT must be planned for at least 4 months and must include luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist
* ADT may have started for no more than 120 days before registration
* The participant must have a primary care provider and/or cardiologist or plan to obtain one
* Comorbidities assessed at study entry using the Adult Comorbidity Evaluation (ACE)-27 instrument (located on the CTSU website)
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03860961
Study Brief:
Protocol Section:
NCT03860961