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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01288534
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of enrollment
* Signed informed consent
* Gleason score ≤ 7
* If Gleason 7 (3+4=7 or 4+3=7) then \<50% of biopsy cores must be positive for any pathologic grade of prostate cancer
* If Gleason score \<7 then there is no limit on the percentage of biopsy cores involved by prostate cancer
* PSA (within 90 days prior to enrollment)
* ≤ 15 ng/ml prior to start of therapy if Gleason ≤ 6 and
* ≤ 10 ng/ml prior to start of therapy if Gleason 7
* No plan to use hormone therapy prior to evidence of biochemical failure(ie: No neoadjuvant or adjuvant ADT)
* Tumor stage: T1a, T1b, T1c, T2a, T2b
* ECOG Performance Status 0-1
Exclusion Criteria:
* A history of other malignancy diagnosed within the previous 60 months except for non-melanoma skin cancer.
* Any patients who have received other investigational therapy within the last 60 days
* Individuals that have previously been implanted with permanent Beacon transponders
* Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip)
* Patients with implanted pacemaker or defibrillators
* Patients who are felt to have body habitus not conducive to tracking with Calypso beacons
* Positive lymph nodes or metastatic disease from prostate cancer
* Tumor stage: T2c, T3, or T4
* Previous pelvic radiation therapy
* Previous surgery or chemotherapy for prostate cancer
* Previous transuretheral resection of the prostate (TURP) or cryotherapy to the prostate
* Prior hormone therapy or plans for concurrent or post treatment adjuvant hormonal therapy or chemotherapy
* Hormone therapy to include LHRH agonist or oral anti-androgen
* Finasteride and Dutasteride use not excluded
* Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiation therapy, and chemotherapy) while on this protocol
* History of Crohn's Disease or Ulcerative Colitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01288534
Study Brief:
Protocol Section:
NCT01288534