Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 8, 2003
May 21, 2014
June 2003
January 2017   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00063882 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • 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.
    Interventions:
    • Radiation: iodine I 125
    • Radiation: palladium Pd 103
    • Radiation: radiation therapy
  • Active Comparator: Arm II
    Patients undergo interstitial brachytherapy only, as in arm I.
    Interventions:
    • Radiation: iodine I 125
    • Radiation: palladium Pd 103
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
588
Not Provided
January 2017   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00063882
RTOG 0232, CDR0000288823, NCI-2009-01091
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Bradley R. Prestidge, MD Memorial Hermann Southwest Hospital
Radiation Therapy Oncology Group
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP