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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00063882
First received: July 8, 2003
Last updated: August 3, 2012
Last verified: February 2012
History of Changes
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.


Condition Intervention Phase
Prostate Cancer
 Radiation: iodine I 125
Radiation: palladium Pd 103
Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Freedom from progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical (i.e., prostate-specific antigen) failure for at least 5 years [ Designated as safety issue: No ]
  • Biochemical failure by the Phoenix definition [ Designated as safety issue: No ]
  • Disease-specific survival [ Designated as safety issue: No ]
  • Local progression [ Designated as safety issue: No ]
  • Distant metastases [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Incidence of "acute" toxicities [ Designated as safety issue: Yes ]
  • Time to "late" 3+ toxicities [ Designated as safety issue: Yes ]
  • Health-related quality of life as measured by EPIC, EQ5D, and AUA-SI from baseline to 4 months (early) and then at 2 years (late) after initiation of therapy [ Designated as safety issue: No ]
  • Feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and external beam radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 586
Study Start Date: June 2003
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
 Radiation: iodine I 125
Given as interstitial seeds
Radiation: palladium Pd 103
Given as interstitial seeds
Radiation: radiation therapy
Given as external beam radiation therapy over 5 weeks
Active Comparator: Arm II
Patients undergo interstitial brachytherapy only, as in arm I.
 Radiation: iodine I 125
Given as interstitial seeds
Radiation: palladium Pd 103
Given as interstitial seeds

Detailed Description:

OBJECTIVES:

  • Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
  • Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
  • Compare morbidity and quality of life of patients treated with these regimens.
  • Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
  • Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
  • Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.

After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • T1c-T2b, N0, M0

  • Intermediate-risk disease, as defined by 1 of the following:

    • Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
    • Gleason score 7 AND PSA < 10 ng/mL
  • No evidence of distant metastases
  • Prostate volume ≤ 60 cc by transrectal ultrasonography
  • American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Patients must use effective contraception
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site
  • No major medical or psychiatric illness that would preclude study therapy
  • No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior neoadjuvant hormonal therapy allowed provided the following are true:

    • Therapy was initiated within 2-6 months of study enrollment
    • Therapy was no more than 6 months in duration
    • Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration
  • No concurrent hormonal therapy

Radiotherapy

  • No prior pelvic radiotherapy

Surgery

  • No prior radical surgery for prostate cancer
  • No prior transurethral resection of the prostate
  • No prior cryosurgery

Other

  • No prior transurethral needle ablation of the prostate
  • No prior transurethral microwave thermotherapy of the prostate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063882

  Show 170 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Bradley R. Prestidge, MD Memorial Hermann Southwest Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00063882     History of Changes
Other Study ID Numbers: CDR0000288823, RTOG-0232, CTSU
Study First Received: July 8, 2003
Last Updated: August 3, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Iodine
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013