Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

NCT02651896 | Unknown DMC

• 1 other identifier: HSL 2015-64
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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:

1. 1.Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or
2. 2.Improving tumour control, mainly freedom from biochemical failure survival.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (4)

• Freedom from biochemical failure survival

  12 and 24 months

• Overall Survival

  12 and 24 months

• Cause specific Survival

  12 and 24 months

• Quality of life

  12 and 24 months

Study Arms (1)

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

Radiation: HypoIGRT

Interventions

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.

HypoIGRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.

You may qualify if:

• Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
• Patients older than 18 years old
• Patients who accept to perform follow up in the radiation oncology department
• Performance Status ≥ 70
• Written informed consent

You may not qualify if:

• Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment
• Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (2)

Hospital Sírio-Libanes

Brasília, Federal District, 71635-610, Brazil

RECRUITING

Hospital Sírio-Libanes

São Paulo, São Paulo, 01308-050, Brazil

RECRUITING

Related Publications (4)

• 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.

  PMID: 21788038 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.

  PMID: 19395194 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.

  PMID: 25367322 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.

  PMID: 22169269 BACKGROUND

Related Links

• Protocol team hospital website.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Luiz Reis, MD, PhD

  Hospital Sírio-Libanes - Ensino e Pesquisa

  STUDY DIRECTOR

Central Study Contacts

Rafael Gadia, MD

CONTACT

+556130447212; rafaelgadia@gmail.com

Fabio Y Moraes, MD

CONTACT

+5511998975336; fymoraes@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiation Oncology - Hospital Sírio Libanês - Unidade Brasília

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 11, 2016
• Study Start: December 20, 2015
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2019
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

BR (2)