A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
Intervention: questionnaire administration (Other)
HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
Intervention: quality-of-life assessment (Procedure)
HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
Intervention: brachytherapy (Radiation)
Outcomes
Primary Outcomes
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
Time Frame: At scheduled 3 month intervals for one year
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
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
Time Frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
urinary and rectal toxicity-see the adverse event tables
Secondary Outcomes
No secondary outcomes reported