Clinical trial NCT01409473: Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer
Official title: A Prospective Protocol of Stereotactic Body Irradiation With Concurrent Intraprostatic Lesion Boost Utilizing Intensity Modulated Radiotherapy for Patients With Low- and Intermediate-Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Stereotactic body radiotherapy
Radiosurgery
Intensity-modulated radiotherapy
SBRT
IMRT
Early-stage prostate cancer
Low-risk prostate cancer
Intermediate-risk prostate cancer
Intraprostatic lesions
IPL
Lead sponsor: Rocky Mountain Cancer Centers
Sponsor class: OTHER
Collaborators: name: Dr. Dennis Carter
First posted: 2011-08-04
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) with simultaneous boost (higher radiation dose) to areas within the prostate with more prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with low- and intermediate-risk localized prostate cancer.

Detailed description: Standard external beam radiation therapy (EBRT) for low- to intermediate-risk prostate cancer involves several weeks of daily treatment sessions. Stereotactic body radiation therapy (SBRT) is a newer form of EBRT that gives fewer treatments but higher doses of radiation per treatment. In many patients there are certain areas within the prostate with more prominent cancerous growth (intraprostatic lesions), which may require higher doses of radiation (boost) to treat effectively. This study will treat the prostate with simultaneous boost(s) to intraprostatic lesion(s) in 5 treatments over 10-14 days.

Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of prostate adenocarcinoma within one year
* Gleason Score 2-7
* Clinical T-stage T1b-T2c (AJCC 7th Edition)
* Clinical Nx or N0, and Mx or M0
* PSA \< 20 ng/mL
* Low or intermediate risk according to NCCN guidelines: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and PSA \< 10 ng/ml; Intermediate: CS T2b-T2c and Gleason 2-6 and PSA \< 10 ng/ml, or CS T1b-T2a and Gleason 7 and PSA \< 10 ng/ml, or CS T1b-T2a and Gleason 2-6 and PSA 10-20ng/mL
* ECOG performance status 0 or 1
* Has had a pre-treatment PSA drawn within a month of the beginning of protocol therapy
* If androgen-deprivation therapy (ADT) has been initiated, must have a documented pre-ADT PSA; this baseline PSA should not be obtained during following periods: 1) 10-day period following prostate biopsy; 2) within 30 days after discontinuation of finasteride; or 3) within 90 days after discontinuation of dutasteride.
* Has completed a baseline health-related quality of life assessment Extended Prostate Cancer Index Composite questionnaire (EPIC-26)
* Has had a history and physical examination (including digital rectal examination and a formal morbidity assessment via the ACE-27) within 60 days
* Morbidity score (via the ACE-27) of none (0), mild (1) or moderate (2)
* Willing and able to use adequate contraception during protocol treatment and for 3 months after the completion of protocol treatment

Exclusion Criteria:

* Invasive (carcinoma in situ is allowed) solid or hematologic malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy to the prostate or lower pelvis
* Prior or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for a different cancer is allowed)
* Implanted hardware near the planning target volume that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion

Primary outcomes:
measure: Biochemical disease-free survival
timeFrame: 5-8 years
Secondary outcomes:
measure: Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities
timeFrame: 30 days from completion of protocol radiotherapy
measure: Grade 3 or higher late gastrointestinal, genitourinary, and erectile toxicities
timeFrame: >30 days to 5 years from completion of protocol radiotherapy
measure: Freedom from failure
timeFrame: 5-8 years
measure: Local recurrence-free survival
timeFrame: 5-8 years
measure: Distant disease-free survival
timeFrame: 5-8 years
measure: Cause-specific survival
timeFrame: 5-8 years
measure: Overall survival
timeFrame: 8-10 years
measure: Health-related quality of life
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers - Littleton
state: Colorado
Study officials:
affiliation: Rocky Mountain Cancer Centers
name: Charles Leonard, MD
role: PRINCIPAL_INVESTIGATOR
References: