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:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00063882
First received: July 8, 2003
Last updated: May 21, 2014
Last verified: May 2014
  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
Intervention Model: Parallel Assignment
Masking: Open Label
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:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Freedom from progression [ Time Frame: From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical failure by the ASTRO definition [ Time Frame: From randomization to the date of PSA failure per the ASTRO definition or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Biochemical failure by the Phoenix definition [ Time Frame: From randomization to the date of PSA failure per the Phoenix definition or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Disease-specific survival [ Time Frame: From randomization to the date of death due to prostate cancer or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Local progression [ Time Frame: From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Distant metastases [ Time Frame: From randomization to the date of metastastic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Incidence of "acute" toxicities [ Time Frame: Toxicity occurring less than or equal to 180 days from the start of radiation. ] [ Designated as safety issue: No ]
  • Time to "late" 3+ toxicities [ Time Frame: Toxicity occurring >180 days from the start of radiation. ] [ Designated as safety issue: No ]
  • Change in health-related quality of life from baseline as measured by EPIC, EQ5D, and AUA-SI [ Time Frame: From randomization to 2 timepoints: 1) 4 months (early) after intiation of therapy and 2) 2 years (late) after initiation of therapy. Analysis occurs after all patients have been potentially followed for 5 years. ] [ 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 [ Time Frame: Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Enrollment: 588
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063882

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

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00063882     History of Changes
Other Study ID Numbers: RTOG 0232, CDR0000288823, NCI-2009-01091
Study First Received: July 8, 2003
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
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 July 20, 2014