Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

NCT ID: NCT00941915

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-09
• Study Completion Date: 2020-07-17

Brief Summary

The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.

Detailed Description

This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.

Conditions

Prostate Cancer

Study Design

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

Study Groups

Stereotactic Radiotherapy

Five fractions of 7.4 Gy each

Group Type: EXPERIMENTAL

SBRT Prostate

Intervention Type: RADIATION

Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.

Interventions

SBRT Prostate

Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.

Intervention Type: RADIATION

Other Intervention Names

Stereotactic body radiation therapy; External beam radiation therapy

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment
• History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment
• Gleason score less than or equal to 7
• Clinical Stage T1-T2c
• PSA
• less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or
• less than or = 10 ng/ml prior to start of therapy if Gleason = 7
• Zubrod Performance Status 0-1
• Age > 40

Exclusion Criteria

• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)
• Evidence of distant metastases
• Regional lymph node involvement
• Significant urinary obstruction
• Estimated prostate gland > 100 grams
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy
• Previous or concurrent cytotoxic chemotherapy for prostate cancer
• Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
• Severe, active comorbidity

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William R Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530.

Reference Type: BACKGROUND

PMID: 16648499 (View on PubMed)

Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.

Reference Type: BACKGROUND

PMID: 16160131 (View on PubMed)

Madsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1099-105. doi: 10.1016/j.ijrobp.2006.10.050.

Reference Type: BACKGROUND

PMID: 17336216 (View on PubMed)

Boyer MJ, Papagikos MA, Kiteley R, Vujaskovic Z, Wu J, Lee WR. Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer. Radiat Oncol. 2017 Jan 13;12(1):14. doi: 10.1186/s13014-016-0758-8.

Reference Type: RESULT

PMID: 28086825 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00018266

Identifier Type: -

Identifier Source: org_study_id