Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033631
• Other study ID #: RTOG-0126
• Secondary ID: CDR0000069306
• Status: Completed
• Phase: Phase 3
• Start date: March 2002
• Est. completion date: December 22, 2022

Study information

• Verified date: December 2022
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1534
• Est. completion date: December 22, 2022
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	McGill Cancer Centre at McGill University	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Doctor H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario
Canada	Cancer Care Program at Thunder Bay Regional Health Sciences	Thunder Bay	Ontario
Canada	Edmond Odette Cancer Centre at Sunnybrook	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	Lovelace Medical Center - Downtown	Albuquerque	New Mexico
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	New York Methodist Hospital	Brooklyn	New York
United States	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Cancer Institute of New Jersey at Cooper University Hospital - Camden	Camden	New Jersey
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Central Maryland Oncology Center	Columbia	Maryland
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Danville Regional Medical Center	Danville	Virginia
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Oncology Center at Saint Margaret Mercy Healthcare Center	Hammond	Indiana
United States	Independence Regional Health Center	Independence	Missouri
United States	Foote Memorial Hospital	Jackson	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas City Cancer Center at St. Joseph's Medical Mall	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Parvin Radiation Oncology	Kansas City	Missouri
United States	Providence Medical Center	Kansas City	Kansas
United States	Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center	Kansas City	Missouri
United States	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri
United States	St. Joseph Medical Center	Kansas City	Missouri
United States	Truman Medical Center - Hospital Hill	Kansas City	Missouri
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Veterans Affairs Medical Center - Long Beach	Long Beach	California
United States	Community Memorial Hospital Cancer Care Center	Menomonee Falls	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Cancer Center at Ball Memorial Hospital	Muncie	Indiana
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Johnson County Radiation Therapy	Overland Park	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Bay Medical	Panama City	Florida
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	MNAP Oncologic Center	Philadelphia	Pennsylvania
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin
United States	Cancer Centers of North Carolina - Raleigh	Raleigh	North Carolina
United States	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina
United States	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Saint Mary's Regional Medical Center	Reno	Nevada
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California
United States	CentraCare Clinic - River Campus	Saint Cloud	Minnesota
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	LDS Hospital	Salt Lake City	Utah
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Shawnee Mission Medical Center	Shawnee Mission	Kansas
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia
United States	Precision Radiotherapy at University Pointe	West Chester	Ohio
United States	Cancer Treatment Center	Wooster	Ohio
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Cranmer-Sargison G. A treatment planning investigation into the dosimetric effects of systematic prostate patient rotational set-up errors. Med Dosim. 2008 Autumn;33(3):199-205. doi: 10.1016/j.meddos.2007.06.005. — View Citation

Potrebko PS, McCurdy BM, Butler JB, El-Gubtan AS, Nugent Z. Optimal starting gantry angles using equiangular-spaced beams with intensity modulated radiation therapy for prostate cancer on RTOG 0126: a clinical study of 5 and 7 fields. Radiother Oncol. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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.	From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.
Secondary	Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition	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.	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.
Secondary	Disease Specific Survival	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.	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.
Secondary	Local Progression	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.	From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Secondary	Distant Metastases	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.	From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Secondary	Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity	Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0	From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint
Secondary	Percentage of Participants With Erectile Disfuction at 12 Months	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.	Twelve months from randomization
Secondary	Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months	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.	Baseline and 12 months from randomization
Secondary	Quality Adjusted Survival by SQLI		From randomization to 5 years.
Secondary	Tumor Control Probability		From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.
Secondary	Normal Tissue Complication Probability		From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.

External Links

•   Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.