Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.

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

Study Overview

• Status: Unknown
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Radiation: HypoIGRT

Detailed Description

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:

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.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Rafael Gadia, MD; Phone Number: +556130447212; Email: rafaelgadia@gmail.com
• Study Contact Backup: Name: Fabio Y Moraes, MD; Phone Number: +5511998975336; Email: fymoraes@gmail.com

Study Locations

• Brazil
  • DF
    • Brasilia, DF, Brazil, 71635-610
      • Recruiting
      • Hospital Sirio-Libanes
      • Contact: Rafael Gadia, MD; Phone Number: +556130447212; Email: rafaelgadia@gmail.com
  • SP
    • São Paulo, SP, Brazil, 01308-050
      • Recruiting
      • Hospital Sirio-Libanes
      • Contact: Fabio Y Moraes, MD; Phone Number: +16472916646; Email: fabio.ymoraes@hsl.org.br
      • Contact: Ana Cristina L Patrocinio, Graduated; Phone Number: +551133944797; Email: ana.patrocinio@hsl.org.br
      • Principal Investigator: Rafael Gadia, MD
      • Sub-Investigator: Gabriela SM Siqueira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

HypoIGRT; Low Risk (T1-T2a, Gleason score 6, and PSA < 10 ng/mL); Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes
• Investigators: Study Director: Luiz Reis, MD, PhD, Hospital Sírio-Libanes - Ensino e Pesquisa

Publications and helpful links

General Publications

• 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.

Helpful Links

• Protocol team hospital website.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HSL 2015-64