Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (SMART)

• ClinicalTrials.gov Identifier: NCT00941915
• Recruitment Status: Completed
• First Posted: July 20, 2009
• Results First Posted: January 24, 2022
• Last Update Posted: January 24, 2022
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: July 17, 2009
• First Posted Date: July 20, 2009
• Results First Submitted Date: June 22, 2021
• Results First Posted Date: January 24, 2022
• Last Update Posted Date: January 24, 2022
• Actual Study Start Date: November 9, 2009
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 17, 2021)

• Number of Participants With Genitourinary Acute Toxicity [ Time Frame: </= 90 days post radiation treatment, a total of 90 days ]
  Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
• Number of Participants With Genitourinary Late Toxicity [ Time Frame: >90 days from the end of treatment, up to 3 years ]
  Genitourinary Late Toxicity is defined as Grade 3 or higher occurring >90 days from the end of radiation treatment
• Number of Participants With Gastrointestinal Acute Toxicity [ Time Frame: </= 90 days post radiation treatment, a total of 90 days ]
  Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
• Number of Participants With Gastrointestinal Late Toxicity [ Time Frame: >90 days from the end of treatment, up to 3 years ]
  Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring > 90 days from the end of radiation treatment

• Original Primary Outcome Measures (submitted: July 17, 2009): Toxicity [ Time Frame: 3 years ]

Current Secondary Outcome Measures (submitted: November 17, 2021)

• Disease Free Survival [ Time Frame: 5 yrs ]
• Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form [ Time Frame: 3 years post-treatment ]
  The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.

Original Secondary Outcome Measures (submitted: July 17, 2009)

• Disease free survival [ Time Frame: 5 yrs ]
• Quality of Life [ Time Frame: 3 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer
• Official Title: A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

Radiation: 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.

Other Names:

• Stereotactic body radiation therapy
• External beam radiation therapy

Study Arms

Experimental: Stereotactic Radiotherapy

Five fractions of 7.4 Gy each

Intervention: Radiation: SBRT Prostate

Publications *

• 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.
• 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. Erratum in: JAMA. 2008 Feb 27;299(8):899-900.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 17, 2009): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 17, 2020
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years to 82 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00941915
• Other Study ID Numbers: Pro00018266
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Duke University
• Study Sponsor: Duke University
• Collaborators: Not Provided

Investigators

• Principal Investigator: William R Lee, MD; Duke University

• PRS Account: Duke University
• Verification Date: November 2021