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Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00033631
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 8, 2017
Last Update Posted : January 18, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: 70.2 Gy 3D-CRT/IMRT Radiation: 79.2 Gy 3D-CRT/IMRT Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2002
Actual Primary Completion Date : April 2014
Actual Study Completion Date : December 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 70.2 Gy
70.2 Gy 3D-CRT/IMRT
 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
Experimental: 79.2 Gy
79.2 Gy 3D-CRT/IMRT
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Percentage of Participants With Erectile Disfuction at 12 Months [ Time Frame: Twelve months from randomization ]
    The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or < half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.

  7. Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months [ Time Frame: Baseline and 12 months from randomization ]

    The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows:

    Improvement: when change >= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM < change < SEM; Declined: when change <= SEM.


  8. Quality Adjusted Survival by SQLI [ Time Frame: From randomization to 5 years. ]
  9. 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. ]
  10. Normal Tissue Complication Probability [ Time Frame: From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033631


Locations
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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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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
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00033631    
Other Study ID Numbers: RTOG-0126
CDR0000069306
First Posted: January 27, 2003    Key Record Dates
Results First Posted: February 8, 2017
Last Update Posted: January 18, 2023
Last Verified: December 2022
Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases