Phase 2 N=255 Randomized Treatment

Radiation Therapy in Treating Patients With Prostate Cancer

Prostate Cancer · Psychosocial Effects of Cancer and Its Treatment · Radiation Toxicity · Sexual Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT01434290 ↗

Enrolled (actual)

255

Serious AEs

0.4%

Results posted

Nov 2017

Primary outcome: Primary: Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points — 30.1; 28.0 percentage of participants — p=0.19

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 36.25 Gy IMRT (Radiation); 51.6 Gy IMRT (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Radiation Therapy Oncology Group
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points	30.1; 28.0	0.19
PRIMARY The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points	45.2; 42.0	0.18
SECONDARY Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm	1.7; 1.7; 0.8; 0.8	—
SECONDARY Rate of PSA Failure	0.0; 0.8; 0.0; 0.8; 3.4; 3.5	—
SECONDARY Rate of Disease-free Survival (DFS)	99.2; 99.2; 99.2; 97.5; 89.6; 92.3	—
SECONDARY Mean Quality Adjusted Life Years at 5 Years	6.13; 4.87	—
SECONDARY Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year	1.79; 0; 0; 0	0.03 sig
SECONDARY The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points	32.9; 30.4	0.39
SECONDARY The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points	36.7; 38.1	0.44
SECONDARY Change From Baseline in EQ-5D Scores	0; 0; 0; 0	0.16
SECONDARY Utilization of Sexual Medications/Devices Questionnaire Response Frequences	6; 7; 30; 29; 2; 5	—
SECONDARY Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy	—	—

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization
History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-6 within 180 days of randomization
Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization
Prostate-specific antigen (PSA) < 10 ng/mL within 60 days prior to registration;
PSA should not be obtained within 10 days after prostate biopsy
No evidence of distant metastases
No regional lymph node involvement

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of 5 years (for example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
No severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition
HIV testing is not required for entry into this protocol
Protocol-specific requirements may also exclude immuno-compromised patients

PRIOR CONCURRENT THERAPY:

No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused ultrasonography (HIFU) for prostate cancer
No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol (DES)), or surgical castration (orchiectomy)
No finasteride within 30 days prior to registration
Prostate-specific antigen (PSA) should not be obtained prior to 30 days after stopping finasteride
No dutasteride within 90 days prior to registration
PSA should not be obtained prior to 90 days after stopping dutasteride
No prior or concurrent cytotoxic chemotherapy for prostate cancer
Patients on Coumadin or other blood-thinning agents are eligible for this study
No concurrent 3D-conformal radiation therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01434290). 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.