Clinical trial NCT00573833: Internal Radiation Therapy in Treating Patients With Prostate Cancer
Official title: A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-12-14
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
timeFrame: At scheduled 3 month intervals for one year
measure: Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
timeFrame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
Secondary outcomes:
Other outcomes:
measure: Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint
timeFrame: week 12 reported
measure: Median International Prostate Symptom Total Score
timeFrame: week 12 reported
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Josh Yamada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael J. Zelefsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Sherri M. Donat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Marco Zaider, PhD
role: PRINCIPAL_INVESTIGATOR
References: