Stereotactic Body Radiation Therapy in Treating Patients With Low- and Low-Intermediate-Risk Prostate Cancer
This study is currently recruiting participants.
Verified April 2013 by Virginia Commonwealth University
Sponsor:
Virginia Commonwealth University
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01737151
First received: November 26, 2012
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
This randomized clinical trial studies stereotactic body radiation therapy in treating patients with low- and low-intermediate-risk prostate cancer. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
| Condition | Intervention |
|---|---|
|
Prostate Adenocarcinoma Stage I Prostate Cancer |
Radiation: stereotactic body radiation therapy Radiation: four fraction split-course SBRT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of 4-Fraction Split-Course Stereotactic Ablative Radiation Therapy of the Treatment of Patients With Low and Low-Intermediate Risk Adenocarcinoma of the Prostate |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- Late toxicity greater than or equal to grade 2 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Will be tested using a continuity corrected chi-square test
Secondary Outcome Measures:
- Biochemical failure as defined by the Phoenix definition [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Acute toxicity greater than or equal to grade 2 as defined by the CTCAE version 4 criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (standard stereotactic body radiation therapy (SBRT)
Patients undergo standard daily fractions of SBRT over 7-8.5 weeks
|
Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Name: SBRT, stereotactic radiation therapy, stereotactic radiotherapy
|
|
Experimental: Arm II (four fraction split-course SBRT)
Patients undergo 2 fractions of SBRT in weeks 1 and 4
|
Radiation: four fraction split-course SBRT
four fraction split-course SBRT
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
SECONDARY OBJECTIVES:
I. To evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule.
II. To determine stereotactic treatment efficacy through biochemical failure (Phoenix criteria).
III. To determine the protocol completion rate.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo standard daily fractions of stereotactic body radiation therapy (SBRT) over 7-8.5 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients must have low or low-intermediate risk adenocarcinoma of the prostate as defined by:
- Histopathology score (Gleason sum) =< 6, and T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) < 10; or
- Histopathology score (Gleason sum) 3+4 = 7 in =< 2 cores, and =< 30% involvement of any core, and T-stage (per current AJCC staging criteria): T1c, and PSA < 10
- No perineural or lymphovascular invasion present in biopsy specimen
- Charlson index of comorbidity score =< 4
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
- Patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment
- Patients with a history of pelvic irradiation for any reason
- Life expectancy < 10 years - Prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two
- Prior radiation therapy, brachytherapy, or cryotherapy
- Prior surgical procedure involving peri-rectal and peri-prostatic area
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737151
Contacts
| Contact: Mitchell Anscher, MD | 804-828-7238 | manscher@mcvh.vcu.edu |
| Contact: Diane Holdford, RN | 804-828-0296 | daholdfo@vcu.edu |
Locations
| United States, Virginia | |
| Virginia Commonwealth University, Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Mitchell Anscher, MD 804-828-7238 manscher@mcvh-vcu.edu | |
| Contact: Diane Holdford, RN 804-828-0296 daholdfo@vcu.edu | |
| Principal Investigator: Mitchell Anscher, MD | |
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
| Principal Investigator: | Mitchell Anscher, M.D. | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01737151 History of Changes |
| Other Study ID Numbers: | MCC-14712, NCI-2012-02545 |
| Study First Received: | November 26, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013