Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer

NCT00941915 | Completed Results

• 1 other identifier: Pro00018266
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Disease Free Survival

  5 yrs

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

  3 years post-treatment

Study Arms (1)

Stereotactic Radiotherapy

EXPERIMENTAL

Five fractions of 7.4 Gy each

Radiation: SBRT Prostate

Interventions

SBRT Prostate 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.

Also known as: Stereotactic body radiation therapy, External beam radiation therapy

Stereotactic Radiotherapy

Eligibility Criteria

• Age: 40 Years - 82 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• 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.

  PMID: 16648499 BACKGROUND

• 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.

  PMID: 16160131 BACKGROUND

• 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.

  PMID: 17336216 BACKGROUND

• 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.

  PMID: 28086825 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Joan Cahill, BSN RN OCN CCRP
• Organization: Assistant Research Practice Manager

joan.cahill@duke.edu

(919) 668-5211

Study Officials

• William R Lee, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 20, 2009
• Study Start: November 9, 2009
• Primary Completion: February 1, 2017
• Study Completion: July 17, 2020
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2021-11

Locations

US (1)