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

Withdrawn before enrolling · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01409473

Run by

Rocky Mountain Cancer Centers

People needed

0

Starts

2011-08-01

Expected to finish

2022-08-01

Last updated by the study team

2014-02-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers - Littleton — Littleton, Colorado, United States

Full record on ClinicalTrials.gov

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