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Trial record 68 of 1447 for:    prostate cancer AND radiation

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033631
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : February 8, 2017
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date  ICMJE April 9, 2002
First Posted Date  ICMJE January 27, 2003
Results First Submitted Date  ICMJE December 16, 2016
Results First Posted Date  ICMJE February 8, 2017
Last Update Posted Date November 20, 2019
Study Start Date  ICMJE March 2002
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
Overall Survival [ Time Frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. ]
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00033631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition [ Time Frame: From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years. ]
    Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.
  • Disease Specific Survival [ Time Frame: From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint. ]
    Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.
  • Local Progression [ Time Frame: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. ]
    Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
  • Distant Metastases [ Time Frame: From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. ]
    Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
  • Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity [ Time Frame: From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint ]
    Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
  • Erectile Function by International Index of Erectile Function (IIEF) [ Time Frame: From randomization to 5 years. ]
  • Global Quality of Life (QOL) by Spitzer QOL Index (SQLI) [ Time Frame: From randomization to 5 years. ]
  • Quality Adjusted Survival by SQLI [ Time Frame: From randomization to 5 years. ]
    This analysis will not be done because there was no difference in survival between the two treatment arms.
  • Tumor Control Probability [ Time Frame: From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis. ]
  • Normal Tissue Complication Probability [ Time Frame: From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Official Title  ICMJE A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

Detailed Description

OBJECTIVES:

  • Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy.
  • Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
  • Compare the probability of tumor control and normal tissue complications in patients treated with these regimens.
  • Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens.
  • Compare the quality of life, including sexual function, of patients treated with these regimens.
  • Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but < 20 ng/mL vs Gleason score 7, PSA < 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days).
  • Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days).

Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: 70.2 Gy 3D-CRT/IMRT
    Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
    Other Names:
    • 3D conformal radiation therapy
    • intensity modulated radiation therapy
  • Radiation: 79.2 Gy 3D-CRT/IMRT
    Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
    Other Names:
    • 3D conformal radiation therapy
    • intensity modulated radiation therapy
Study Arms  ICMJE
  • Active Comparator: 70.2 Gy
    70.2 Gy 3D-CRT/IMRT
    Intervention: Radiation: 70.2 Gy 3D-CRT/IMRT
  • Experimental: 79.2 Gy
    79.2 Gy 3D-CRT/IMRT
    Intervention: Radiation: 79.2 Gy 3D-CRT/IMRT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
1532
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Clinical stage T1b-T2b
  • Meets one of the following criteria:

    • Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL
    • Gleason score 7 AND PSA < 15 ng/mL
  • No regional lymph node involvement
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
  • No other major medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior cytotoxic chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • At least 3 months since prior finasteride
  • No other prior hormonal therapy, including:

    • Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
    • Antiandrogens (e.g., flutamide or bicalutamide)
    • Estrogens (e.g., diethylstilbestrol)
  • No concurrent (neoadjuvant or adjuvant) hormonal therapy

Radiotherapy:

  • No prior pelvic irradiation or brachytherapy

Surgery:

  • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • No prior surgical castration (bilateral orchiectomy)

Other:

  • At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00033631
Other Study ID Numbers  ICMJE RTOG-0126
CDR0000069306
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radiation Therapy Oncology Group
Study Sponsor  ICMJE Radiation Therapy Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jeff M. Michalski, MD Washington University - Saint Louis
Study Chair: James Purdy, Ph.D. UC Davis
Study Chair: Deborah W Bruner, Ph.D. Emory University
Study Chair: Mahul Amin, M.D. Cedars-Sinai
PRS Account Radiation Therapy Oncology Group
Verification Date May 2019

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