Brief Summary

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,116

participants targeted

Target at P75+ for phase_3 prostate-cancer

Timeline

Completed

Started Apr 2006

Longer than P75 for phase_3 prostate-cancer

Geographic Reach

2 countries

296 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

16.7 years study duration

Study Start

First participant enrolled

April 1, 2006

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed

9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

April 13, 2017

Completed

5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed

Last Updated

January 18, 2023

Status Verified

December 1, 2022

Enrollment Period

9.3 years

First QC Date

May 30, 2006

Results QC Date

November 29, 2016

Last Update Submit

December 27, 2022

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

Five-year Disease-free Survival (DFS) Rate
Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.
Analysis occurs after all patients have been followed for five years.

Secondary Outcomes (11)

Five-year Local Progression Rate
Analysis occurs after all patients have been followed for five years.
Five-year Disease-specific Survival Rate
Analysis occurs after all patients have been followed for five years.
Five-year PSA Failure Rate
Analysis occurs after all patients have been followed for five years.
Five-year Overall Survival Rate
Analysis occurs after all patients have been followed for five years.
Frequency of Patients With GU and GI Acute and Late Toxicity
Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.
+6 more secondary outcomes

Other Outcomes (1)

Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses
From baseline to 5 years from the start of treatment.

Study Arms (2)

Conventional 3D-CRT

ACTIVE COMPARATOR

Conventional 3D-CRT or IMRT to 73.8 Gy in 41 fractions

Radiation: Conventional 3D-CRT or IMRT

Hypofractionated 3D-CRT

EXPERIMENTAL

Hypofractionated 3D-CRT or IMRT to 70 Gy in 28 fractions

Radiation: Hypofractionated 3D-CRT or IMRT

Interventions

Conventional 3D-CRT or IMRTRADIATION

Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy

Also known as: 3-dimensional conformal radiation therapy, Intensity-modulated radiation therapy (IMRT)

Conventional 3D-CRT

Hypofractionated 3D-CRT or IMRTRADIATION

Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.

Also known as: Hypofractionated 3-dimensional conformal radiation therapy, Intensity-modulated radiation therapy (IMRT)

Hypofractionated 3D-CRT

Eligibility Criteria

Age18 Years - 120 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate within the past 6 months * Clinical stage T1-2c * Combined Gleason score 2-6 * Prostate-specific antigen (PSA) \< 10 ng/mL within the past 6 months * PSA evaluated at least 10 days after prostate biopsy * For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride * For patients who received dutasteride, PSA evaluated at least 90 after completion of dutasteride * No regional lymph node involvement * No distant metastases PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * No transmural myocardial infarction within the past 6 months * No acute bacterial or fungal infection requiring IV antibiotics * No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment * No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * No known AIDS * No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity) * No other severe, active comorbidity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radical prostatectomy or cryosurgery for prostate cancer * No prior hormonal therapy, including any of the following: * Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) * Antiandrogens (e.g., flutamide or bicalutamide) * Estrogens \[e.g., diethylstilbestrol (DES)\] * Surgical castration (bilateral orchiectomy) * No prior pelvic radiotherapy or prostate brachytherapy * No prior or concurrent cytotoxic chemotherapy for prostate cancer * At least 30 days since prior finasteride * At least 90 days since prior dutasteride * No concurrent neoadjuvant or adjuvant hormonal therapy * Concurrent warfarin or other blood-thinning agents allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Radiation Therapy Oncology Grouplead
National Cancer Institute (NCI)collaborator
NRG Oncologycollaborator

Study Sites (296)

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Arizona Oncology - Tucson

Tucson, Arizona, 85704, United States

Location

Auburn Radiation Oncology

Auburn, California, 95603, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Radiation Oncology Centers - Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

Sutter Health - Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Alta Bates Summit Medical Center - Summit Campus