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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: SBRT Prostate

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic Radiotherapy; Five fractions of 7.4 Gy each	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: External beam radiation therapy; Stereotactic body radiation therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: William R Lee, MD, Duke University

Publications and helpful links

General 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. doi: 10.1200/JCO.2005.05.2530.
• 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. 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. doi: 10.1016/j.ijrobp.2006.10.050.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2009
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): July 17, 2020

Study Registration Dates

• First Submitted: July 17, 2009
• First Submitted That Met QC Criteria: July 17, 2009
• First Posted (Estimate): July 20, 2009

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: IMRT; Prostate; SBRT; Calypso; Radiation; Prostatic Neoplasms; Cancer of Prostate; CaP; ExacTrac
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Pro00018266

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No