Internal Radiation Therapy in Treating Patients With Prostate Cancer
Completed · Not applicable
Conditions studied: Prostate Cancer
In brief
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.
Key facts
- Study ID
- NCT00573833
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 23
- Starts
- 2007-11-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2017-10-20
Who can join
Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
- PSA 10-20 ng/mL
- Gleason score ≥ 7
- Stage ≥ T2b AND < T3
- Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
- Prostate size < 60 cc by MRI or CT imaging
- International Prostate Symptom Score Index ≤ 15
You may not qualify if…
- Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
- Suspected extracapsular disease will not be considered an exclusion criteria
- PSA > 20 ng/mL
- Presence of distant metastases
- PATIENT CHARACTERISTICS:
- WBC ≥ 3,500/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.5 mg/dL
- Liver function tests ≤ 1.5 times normal
- INR ≤ 2.5
- Able to complete quality of life questionnaires
- Able to give informed consent
- No active perineal infections
- No history of urethral stricture
- No prior history of pelvic malignancy
- No prior history of lymphoma disease, ulcerative colitis, or anal fissures
- No contraindications to general anesthesia
- No pacemaker
- PRIOR CONCURRENT THERAPY:
- No prior transurethral resection of the prostate
- No prior pelvic radiotherapy
- No prior treatment for prostate cancer except for hormone therapy
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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