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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT01023061
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent
* Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial placement
* Written Authorization for Use and Release of Health and Research Study Information has been obtained
* Histologically proven adenocarcinoma of the prostate
* Patients must be candidates for short or long term androgen deprivation in combination with external beam radiotherapy (RT) based on the following criteria:
* Intermediate Risk Disease: T2b/c, or Gleason 7, or Prostate Specific Antigen 10-20
* High Risk Disease: Gleason 8-10, or Prostate specific antigen\> 20, or T3/4
* Patients may not have received any prior pharmacologic therapy or radiation therapy (RT) for prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Karnofsky \>= 60%
* Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the Principal Investigator
* White blood cell count: \>= 3,000/mm\^3
* Absolute granulocyte count: \>= 1,000/mm\^3
* Platelets: \>= 100,000/mm\^3
* Hemoglobin \>= 10g/dL
* Potassium \>= 3.5 mmol/L
* Serum creatinine: =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 2.5 x ULN
* Alanine transaminase (ALT) \< 2.5 x ULN
* Total bilirubin: =\< 1.5 x ULN (except for patients with documented Gilbert's disease)
Exclusion Criteria:
* Patients may not be receiving any investigational agents
* Concurrent enrollment in another clinical investigational drug or device study is prohibited
* The concurrent administration of other anticancer therapy, including cytotoxic or hormonal agents (except Luteinizing hormone releasing hormone agonists), or immunotherapy, is prohibited during neoadjuvant concurrent and adjuvant therapy
* Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
* Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
* Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible
* History of pituitary or adrenal dysfunction
* Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible
* Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible
* Concomitant therapy with any of the following listed is prohibited: 5 alpha-reductase inhibitor (finasteride, dutasteride); ketoconazole, diethylstilbestrol, and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer; radiopharmaceuticals such as strontium (89Sr) or samarium (153Sm); Aldactone, Spironol (spironolactone); estrogens, testosterone, progesterones, herbal medications
* Patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the Principal Investigator on a case by case basis
* Use of other investigational drug therapy for any reason is prohibited
* Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible
* Patients who have chronic active hepatitis or acute hepatitis will not be eligible
* Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible
* Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
* Uncontrolled hypertension within the screening period (systolic blood pressure \[BP\] \>= 160 mmHg or diastolic BP \>= 95 mmHg)
* Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
* History of congestive heart failure of any severity
* Other active malignancy, except non-melanoma skin cancer and superficial bladder cancer
* History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
* Patients with diabetes not controlled with diet alone (i.e. requiring insulin or oral hypoglycemics)
* Patients unwilling to use contraceptives while on study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01023061
Study Brief:
Protocol Section:
NCT01023061