Radiation Therapy in Treating Patients With Stage II Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00033631
First received: April 9, 2002
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: 3D-CRT or IMRT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate-specific antigen 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 occurs after patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Grade 2 or greater genitourinary or gastrointestinal toxicity [ Time Frame: From the start of treatment to last follow-up. ] [ Designated as safety issue: Yes ]
  • Erectile Function by International Index of Erectile Function (IIEF) [ Time Frame: From randomization to 5 years. ] [ Designated as safety issue: No ]
  • Global Quality of Life (QOL) by Spitzer QOL Index (SQLI) [ Time Frame: From randomization to 5 years. ] [ Designated as safety issue: No ]
  • Quality adjusted survival by SQLI [ Time Frame: From randomization to 5 years. ] [ Designated as safety issue: No ]

Enrollment: 1532
Study Start Date: March 2002
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo standard-dose three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for 7.8 weeks (39 treatment days).
Radiation: 3D-CRT or IMRT
Given 5 days a week for 7.8 or 8.8 weeks
Experimental: Arm II
Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days).
Radiation: 3D-CRT or IMRT
Given 5 days a week for 7.8 or 8.8 weeks

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  • Fertile patients must use effective contraception

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 prostatic 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 PC SPES
  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: NCT00033631

  Show 86 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Jeff M. Michalski, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00033631     History of Changes
Other Study ID Numbers: RTOG-0126, CDR0000069306
Study First Received: April 9, 2002
Last Updated: May 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014