Phase 3 N=1,115 Randomized Treatment

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00331773 ↗

Enrolled (actual)

1,115

Serious AEs

5.6%

Results posted

Apr 2017

Primary outcome: Primary: Five-year Disease-free Survival (DFS) Rate — 85.3; 86.3 percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Conventional 3D-CRT or IMRT (Radiation); Hypofractionated 3D-CRT or IMRT (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Radiation Therapy Oncology Group
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Five-year Disease-free Survival (DFS) Rate	85.3; 86.3	<0.001 sig
SECONDARY Five-year Local Progression Rate	1.2; 0.4	—
SECONDARY Five-year Disease-specific Survival Rate	0.2; 0.2	—
SECONDARY Five-year PSA Failure Rate	8.1; 6.3	< 0.001 sig
SECONDARY Five-year Overall Survival Rate	93.2; 92.5	0.008 sig
SECONDARY Frequency of Patients With GU and GI Acute and Late Toxicity	55; 58; 3; 4; 145; 147	0.85
SECONDARY Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC	-4; -3.7; 0; -1.5; -8.1; -7.8	0.72
SECONDARY The Utilization of Sexual Medications/Devices Questionaire	2.0; 0.0; 24.5; 23.0; 2.5; 0.6	—
SECONDARY Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25	31.2; 31.8; 31.2; 32.2; 31.1; 31.7	0.55
SECONDARY EQ-5D Scores	85.0; 82.0; 1.0; 1.0; 85.0; 85.0	0.037 sig
SECONDARY Assessment of Trade-off Between Disease-free Survival and Quality of Life.	—	—
SECONDARY Statistical Modeling of Genomic Biomarkers	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00331773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.