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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SBRT Prostate

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring CaP, SBRT, Prostate, ExacTrac, Calypso, IMRT, Radiation, Cancer of Prostate, Prostatic Neoplasms

Eligibility Criteria

40 Years - 82 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Radiotherapy

Arm Description

Five fractions of 7.4 Gy each

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

Disease Free Survival

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.

Full Information

NCT ID

NCT00941915

First Posted

July 17, 2009

Last Updated

November 17, 2021

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT00941915

Brief Title

Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

Acronym

SMART

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 9, 2009 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

July 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

CaP, SBRT, Prostate, ExacTrac, Calypso, IMRT, Radiation, Cancer of Prostate, Prostatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic Radiotherapy

Arm Type

Experimental

Arm Description

Five fractions of 7.4 Gy each

Intervention Type

Radiation

Intervention Name(s)

SBRT Prostate

Other Intervention Name(s)

Stereotactic body radiation therapy, External beam radiation therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Genitourinary Acute Toxicity

Description

Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment

Time Frame

</= 90 days post radiation treatment, a total of 90 days

Title

Number of Participants With Genitourinary Late Toxicity

Description

Genitourinary Late Toxicity is defined as Grade 3 or higher occurring >90 days from the end of radiation treatment

Time Frame

>90 days from the end of treatment, up to 3 years

Title

Number of Participants With Gastrointestinal Acute Toxicity

Description

Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment

Time Frame

</= 90 days post radiation treatment, a total of 90 days

Title

Number of Participants With Gastrointestinal Late Toxicity

Description

Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring > 90 days from the end of radiation treatment

Time Frame

>90 days from the end of treatment, up to 3 years

Secondary Outcome Measure Information:

Title

Disease Free Survival

Time Frame

5 yrs

Title

Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form

Description

The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.

Time Frame

3 years post-treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

82 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William R Lee, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16648499

Citation

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.

Results Reference

background

PubMed Identifier

16160131

Citation

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.

Results Reference

background

PubMed Identifier

17336216

Citation

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.

Results Reference

background

PubMed Identifier

28086825

Citation

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.

Results Reference

result

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Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

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