Clinical trial NCT00941915: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: CaP
SBRT
Prostate
ExacTrac
Calypso
IMRT
Radiation
Cancer of Prostate
Prostatic Neoplasms
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Genitourinary Acute Toxicity
timeFrame: </= 90 days post radiation treatment, a total of 90 days
measure: Number of Participants With Genitourinary Late Toxicity
timeFrame: >90 days from the end of treatment, up to 3 years
measure: Number of Participants With Gastrointestinal Acute Toxicity
timeFrame: </= 90 days post radiation treatment, a total of 90 days
measure: Number of Participants With Gastrointestinal Late Toxicity
timeFrame: >90 days from the end of treatment, up to 3 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 yrs
measure: Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form
timeFrame: 3 years post-treatment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: William R Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.