Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer
NCT ID: NCT02651896
Last Updated: 2017-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
130 participants
OBSERVATIONAL
2015-12-20
2019-12-31
Brief Summary
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1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or
2. Improving tumour control, mainly freedom from biochemical failure survival.
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Detailed Description
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Primary Outcome Measures:
1\. Acute and late radiation induced toxicities.
Secondary Outcome Measures:
1. Freedom from prostate cancer recurrence - freedom from biochemical failure survival;
2. Cause specific and overall survival
3. Aspects of quality of life and health economics
Study Design:
Allocation: Prospective allocation Endpoint Classification: Feasibility Study (Toxicity assessment) Intervention Model: Single Assignment Masking: Open Label Primary Purpose: Treatment
Eligibility
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Study Population:
Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HypoIGRT
1. Low Risk (T1-T2a, Gleason score 6, and PSA \< 10 ng/mL)
2. Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL)
3. High Risk (T3 - 4 , Gleason 8-10, and/or PSA \> 20 ng/mL) Neoadjuvant hormone therapy is allowed on groups 2 and 3
HypoIGRT
Hypofractionated intensity modulated and image guided radiotherapy 60 Gy in 20 fractions over four weeks for the prostate gland to all groups.
For intermediate and high risk group: seminal vesicle will be included: 48 Gy in 20 fractions over 4 weeks (proximal third to half on physicians description).
Image guidance with cone beam CT will be mandatory before every treatment fraction.
Interventions
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HypoIGRT
Hypofractionated intensity modulated and image guided radiotherapy 60 Gy in 20 fractions over four weeks for the prostate gland to all groups.
For intermediate and high risk group: seminal vesicle will be included: 48 Gy in 20 fractions over 4 weeks (proximal third to half on physicians description).
Image guidance with cone beam CT will be mandatory before every treatment fraction.
Eligibility Criteria
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Inclusion Criteria
2. Patients older than 18 years old
3. Patients who accept to perform follow up in the radiation oncology department
4. Performance Status ≥ 70
5. Written informed consent
Exclusion Criteria
2. Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)
18 Years
MALE
No
Sponsors
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Hospital Sirio-Libanes
OTHER
Responsible Party
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Rafael Gadia
Head of Radiation Oncology - Hospital Sírio Libanês - Unidade Brasília
Principal Investigators
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Luiz Reis, MD, PhD
Role: STUDY_DIRECTOR
Hospital Sírio-Libanes - Ensino e Pesquisa
Locations
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Hospital Sírio-Libanes
Brasília, Federal District, Brazil
Hospital Sírio-Libanes
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Chang P, Szymanski KM, Dunn RL, Chipman JJ, Litwin MS, Nguyen PL, Sweeney CJ, Cook R, Wagner AA, DeWolf WC, Bubley GJ, Funches R, Aronovitz JA, Wei JT, Sanda MG. Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer. J Urol. 2011 Sep;186(3):865-72. doi: 10.1016/j.juro.2011.04.085. Epub 2011 Jul 23.
Leborgne F, Fowler J. Late outcomes following hypofractionated conformal radiotherapy vs. standard fractionation for localized prostate cancer: a nonrandomized contemporary comparison. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1441-6. doi: 10.1016/j.ijrobp.2008.10.087. Epub 2009 Apr 22.
Moraes FY, Siqueira GM, Abreu CE, da Silva JL, Gadia R. Hypofractioned radiotherapy in prostate cancer: is it the next step? Expert Rev Anticancer Ther. 2014 Nov;14(11):1271-6. doi: 10.1586/14737140.2014.972380.
Dearnaley D, Syndikus I, Sumo G, Bidmead M, Bloomfield D, Clark C, Gao A, Hassan S, Horwich A, Huddart R, Khoo V, Kirkbride P, Mayles H, Mayles P, Naismith O, Parker C, Patterson H, Russell M, Scrase C, South C, Staffurth J, Hall E. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Lancet Oncol. 2012 Jan;13(1):43-54. doi: 10.1016/S1470-2045(11)70293-5. Epub 2011 Dec 12.
Related Links
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Protocol team hospital website.
Other Identifiers
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HSL 2015-64
Identifier Type: -
Identifier Source: org_study_id
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