Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02651896
• Other study ID #: HSL 2015-64
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2016
• Last updated: August 24, 2017
• Start date: December 20, 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2017
• Source: Hospital Sirio-Libanes
• Contact: Rafael Gadia, MD
• Phone: +556130447212
• Email: rafaelgadia[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or

2. Improving tumour control, mainly freedom from biochemical failure survival.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Sírio-Libanes	Brasilia	DF
Brazil	Hospital Sírio-Libanes	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Freedom from biochemical failure survival	Prostate-Specific Antigen (PSA) values	12 and 24 months
Secondary	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
Secondary	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
Secondary	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

External Links

•   Protocol team hospital website.