A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Outcome Time Frame:
At scheduled 3 month intervals for one year
Safety Issue:
No
Principal Investigator
Josh Yamada, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
07-120
NCT ID:
NCT00573833
Start Date:
November 2007
Completion Date:
September 2013
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
