Internal Radiation Therapy in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer. To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity < 10% and grade 3 rectal toxicity < 10%). Secondary To achieve adequate dosimetric coverage of the prostate comparable to current standards. To assess the effect of treatment on sexual function. OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days. Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit. After completion of study treatment, patients are followed every 3 months for 1 year.

Official Title
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A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HDR Brachytherapy<br>9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days | Other: questionnaire administration<br> <br> Procedure: quality-of-life assessment<br> <br> Radiation: brachytherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity | Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as > or = grade 3 NCI CTC toxicity | At scheduled 3 month intervals for one year | 
| Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity | urinary and rectal toxicity-see the adverse event tables | Within 90 days of treatment (early toxicities) or after 90 days (late toxicities) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer