Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer

NCT ID: NCT01409473

Last Updated: 2014-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2022-08-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate SBRT

Prostate SBRT with concurrent boost to intraprostatic lesion (IPL) will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.

Group Type: EXPERIMENTAL

Prostate SBRT with concurrent boost to intraprostatic lesion(s)

Intervention Type: RADIATION

40 Gy in 5 fractions to prostate for low-risk and 45 Gy in 5 fractions to prostate for intermediate-risk patients, and 50 Gy in 5 fractions to intraprostatic lesion(s), delivered over 10-14 days on preferably every other day.

Interventions

Prostate SBRT with concurrent boost to intraprostatic lesion(s)

40 Gy in 5 fractions to prostate for low-risk and 45 Gy in 5 fractions to prostate for intermediate-risk patients, and 50 Gy in 5 fractions to intraprostatic lesion(s), delivered over 10-14 days on preferably every other day.

Intervention Type: RADIATION

Other Intervention Names

Stereotactic surgery to the prostate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. Dennis Carter

UNKNOWN

Sponsor Role: collaborator

Rocky Mountain Cancer Centers

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Leonard, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Cancer Centers

Locations

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, United States

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, United States

Countries

United States

Other Identifiers

WIRB #20111125

Identifier Type: OTHER

Identifier Source: secondary_id

511-03

Identifier Type: -

Identifier Source: org_study_id