Condition category
Cancer
Date applied
11/07/2018
Date assigned
23/07/2018
Last edited
05/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Radiotherapy is a treatment where radiation is used to kill cancer cells and can be used to treat prostate cancer. The effectiveness of radiotherapy for the treatment of prostate cancer improves when high doses are delivered to the prostate, especially in aggressive, localised prostate cancer. The standard method of radiotherapy is to deliver small daily doses over the course of 8 weeks; however, as the dose increases over this time, so do the side effects.
Recent evidence shows that, instead of small doses over a longer time period, higher daily doses over a few weeks, mean that higher doses of radiotherapy can be given without increasing the side effects of the treatment, along with improving rates of curing the cancer. This has been shown in patients with low-risk and some patients with intermediate-risk prostate cancer.
We aim to look at whether similar results can be achieved for patients with intermediate-risk and high-risk prostate cancer through 8 days of high dose radiotherapy.

Who can participate?
Localised prostate cancer patients

What does the study involve?
All participants receive high dose radiotherapy on 8 days across 3 weeks, along with traditional androgen deprivation therapy. Additionally, patients will be regularly tested for toxicity, PSA levels and metastasis for 10 years following the study.

What are the possible benefits and risks of participating?
The benefits to participants of taking part include potential curing of their cancer with reduced side effects, along with an improved quality of life. Additionally, the treatment scheme is short, which is more convenient for patients. A possible risk of taking part is unexpected toxicity/side effects.

Where is the study run from?
Salamanca University Hospital, Spain

When is the study starting and how long is it expected to run for?
January 2012 to December 2022

Who is funding the study?
Castille-Leon Autonomous Community public health system (Spain)

Who is the main contact?
Dr Victor Macias-Hernandez (radiation oncologist/clinical oncologist)
victormaciash@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr VICTOR MACIAS-HERNANDEZ

ORCID ID

http://orcid.org/0000-0003-2904-5715

Contact details

Paseo de San Vicente
Salamanca
37007
Spain
+34687481166
victormaciash@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GRS 903/A/14

Study information

Scientific title

Phase II single-centre trial of Extreme Hypofractionated RAdiotherapy for low, intermediate and high-risk localised Prostate cancer

Acronym

EHRAP

Study hypothesis

Late toxicity, quality of life and biochemical-free survival outcomes after extreme hypofractionated radiotherapy for localized prostate cancer are not inferior to normofractionated or moderate hypofractionated radiotherapy

Ethics approval

The Spanish Agency of Medicines and Medical Devices (AEMPS) , 29/01/2013, PI 120413

Study design

Interventional prospective single-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Low, intermediate and highrisk prostate cancer

Intervention

Participants with low, intermediate and high risk prostate cancer received extreme hypofractionated radiotherapy using helical tomotherapy, with online guided MVCT and an endorectal balloon. This radiotherapy delivered 8 fractions of 5.65 Gy radiation over 3 weeks. Additionally, participants received androgen deprivation therapy as usually prescribed in normal standard - for those with intermediate-risk prostate cancer, this consisted of one 6 month LHRH analogue and 1 month bicalutamide; for those with high-risk prostate cancer, this consisted of 2-3 years of 6 month LHRH analogue and 1 month bicalutamide.
Patients will be interviewed at least 2, 6, 12, 18, 24, 30, 36, 48 and 60 months after radiotherapy and every year afterwards up to 10 years, and will be asked about symptoms, along with undergoing urine and blood tests and quality of life questionnaires. At each visit, the following will be tested:
1. Urinary and intestinal toxicity, if any, according to CTCAE scale
2. Health-related quality of life
3. PSA levels (from blood tests performed a few weeks before each visit). If a PSA relapse is found, a rectal examination will be performed to detect a local clinical relapse.
4. Metastases (examined through CT scans and bone scans)

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

The following are measured at the baseline and 2, 6, 12, 18, 24, 30, 36, 48 and 60 months after radiotherapy and every year afterwards:
1. Urinal and intestinal toxicities measured using CTCAE (Common Toxicity Criteria Adverse Effects) scale
2. Health-related quality of life measured using EPIC-26 (Expanded Prostate Cancer Index Composite short form)

Secondary outcome measures

1. PSA relapse free survival (nadir+2 ng/ml) is measured using total PSA levels (determined through blood test performed a few weeks before visit) measured at the baseline and 2, 6, 12, 18, 24, 30, 36, 48 and 60 months after radiotherapy and every year afterwards
2. Metastases-free survival is measured using a CT scan and bone scan, evaluated at the baseline and every 6 months only after a biochemical relapse is diagnosed (PSA > 2 ng + nadir, ASTRO definition)

Overall trial start date

01/01/2012

Overall trial end date

31/07/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. cT1-T3 N0 M0 prostate cancer
2. International Prostate Symptoms Score < 21
3. No acute urinary retention or urethral surgery in the last 6 months
4. Aged 18 years or older
5. Signed specific informant consent form

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

120

Participant exclusion criteria

1. Hip prosthesis
2. Contraindication for radical radiotherapy such as active inflamatory bowel disease, previous pelvic radiotherapy
3. Intense low urinary tract symptoms, IPSS > 20
4. Inability to understand and appreciate the nature and consequences of health decisions

Recruitment start date

01/06/2013

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Complejo Asistencial Universitario de Salamanca (Salamanca University Hospital)
Paseo de San Vicente, 137
Salamanca
37007
Spain

Sponsor information

Organisation

Hospital Universitario de Salamanca (Salamanca University Hospital)

Sponsor details

Paseo de San Vicente
Salamanca
37007
Spain
+34923291200
vamacias@saludcastillayleon.es

Sponsor type

Hospital/treatment centre

Website

https://www.saludcastillayleon.es/CASalamanca/es

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Spanish Autonomous Comunity grant code GRS 903/A/14, from SACYL (Castille and Leon Public Health Service)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Accepted oral communication at American Society of Radiation Oncology annual meeting on october 2018.
To send to a peer-review journal in 2019.
Updated results with longer follow-up to be published in 2021.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

01/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

- 154 patients treated by 12/2017.
- Median follow-up: 36 months.
- More than 50% of patients are unfavorable and high- isk patients
- Late CTCAE toxicity grade 2-3 and 3-year biochemical survival not inferior to published prostate cancer radiotherapy trials
- EPIC scores not statistically different from baseline after 6 months in most domains

Publication list

1. 2014 early toxicity results in https://www.ncbi.nlm.nih.gov/pubmed/25505734 and https://www.ncbi.nlm.nih.gov/pubmed/23928833
2. 2018 results in: https://doi.org/10.1016/j.ijrobp.2018.06.269

Publication citations

Additional files

Editorial Notes

05/12/2018: Publication reference added.