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Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:
The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.
Primary Outcome Measures:
1. Acute and late radiation induced toxicities.
Secondary Outcome Measures:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HypoIGRT |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HypoIGRT | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. | According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5 | During and up to 90 days after treatment ends (acute event) |
| Overall Acute Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. | According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5 | During and up to 90 days after treatment ends (acute event) |
| Overall Late Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. | According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5. | After 90 days up to 24 months from treatment (late event) |
| Overall Late Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. | According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5. | After 90 days up to 24 months from treatment (late event) |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from biochemical failure survival | Prostate-Specific Antigen (PSA) values | 12 and 24 months |
| Overall Survival | Defined as the percentage of participant on treatment group who are alive at 12 and 24 months after the start of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafael Gadia, MD | Contact | +556130447212 | rafaelgadia@gmail.com | |
| Fabio Y Moraes, MD | Contact | +5511998975336 | fymoraes@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luiz Reis, MD, PhD | Hospital Sírio-Libanes - Ensino e Pesquisa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sírio-Libanes | Recruiting | Brasília | Federal District | 71635-610 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21788038 | Background | 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. | |
| 19395194 |
| Label | URL |
|---|---|
| Protocol team hospital website. | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 12 and 24 months |
| Cause specific Survival | Defined as the cancer survival in the absence of other causes of death at 12 and 24 months after the start of treatment. | 12 and 24 months |
| Quality of life | The Expanded Prostate Cancer Index Composite (EPIC) - Brazilian Portuguese version. will be applied to assess urinary, bowel and sexual functions. | 12 and 24 months |
| Hospital Sírio-Libanes | Recruiting | São Paulo | São Paulo | 01308-050 | Brazil |
|
| Background |
| 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. |
| 25367322 | Background | 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. |
| 22169269 | Background | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |