Internal Radiation Therapy in Treating Patients With Prostate Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Radiation: brachytherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)	week 12 reported
Median International Prostate Symptom Total Score	Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92).	week 12 reported

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Josh Yamada, MD, Memorial Sloan Kettering Cancer Center; Principal Investigator: Michael J. Zelefsky, MD, Memorial Sloan Kettering Cancer Center; Principal Investigator: Sherri M. Donat, MD, Memorial Sloan Kettering Cancer Center; Principal Investigator: Marco Zaider, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 13, 2007
• First Submitted That Met QC Criteria: December 13, 2007
• First Posted (Estimate): December 14, 2007

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 07-120; MSKCC-07120