Condition category
Cancer
Date applied
08/12/2017
Date assigned
14/12/2017
Last edited
14/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Prostate cancer is a common cancer in men. Patients with prostate cancer often undergo radiotherapy as a part of their cancer treatment. Radiotherapy is a treatment where radiation is used to kill cancer. Radiotherapy is an effective treatment, but patients can be affected by significant side effects, that can adversely condition their quality of life. New radiotherapy technologies helped in highly reducing the proportion of patients experiencing side-effects. Nevertheless, a portion of patient still suffer of radioinduced toxicity and the availability of tools predicting unusual radiation toxicity could be crucial in improving the potential of individualising the treatment. A recent “hot topic” in prostate cancer radiotherapy is the observed association intestinal side effects and the presence of abdominal surgery before radiotherapy. The reasons for this are still unknown and only some hypothesis can be suggested. The hypothesis investigated in this trial is that a previous surgery may influence plasma level of inflammatory molecules and this fact might result in an increased radiosensitivity. The aim of this study is to determine the plasma levels of some inflammatory molecules at different times during treatment and to measure if these levels of inflammatory molecules are associated with the presence of an abdominal surgery before radiotherapy or with the insurgence of radiation induced intestinal side-effects.

Who can participate?
Adults aged 18 to 80 years old with prostate cancer who are undergoing radiotherapy.

What does the study involve?
There is no change to standard radiotherapy treatment is foreseen. Participating patients are asked to have some blood samples before/during and after radiotherapy and to fill in self-reported questionnaires which will be used to score in an objective way their intestinal side-effects.

What are the possible benefits and risks of participating?
There are no direct benefits or risks associated with participation.

Where is the study run from?
Fondazione IRCCS Istituto Nazionale dei Tumori (Italy)

When is the study starting and how long is it expected to run for?
December 2010 to July 2017

Who is funding the study?
Fondazione IRCCS Istituto Nazionale dei Tumori (Italy)

Who is the main contact?
Dr Tiziana Rancati

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tiziana Rancati

ORCID ID

Contact details

Prostate Cancer Program
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
20133
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

INT 67/10

Study information

Scientific title

Prospective evaluation of plasma levels of soluble mediators associate to inflammatory response in prostate cancer patients undergoing radiotherapy and association with acute and late rectal toxicity

Acronym

Study hypothesis

The working hypothesis, which guided the here presented study, was that a previous surgery may influence plasma level of inflammatory molecules/cytokines and this fact might result in an enhanced radiosensitivity. Surgery could function as a potential precursor of inflammatory patterns that could lead to an increased sensitivity even far from the surgical injury through cytokines mediated reactions.

Ethics approval

Ethics Board of Fondazione IRCCS Istituto Nazionale dei Tumori, 22/12/2010, ref: INT 67/10

Study design

Observational study. 20 consecutive patients undergoing radical prostate cancer radiotherapy. Single centre.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prostate cancer

Intervention

Patients with a diagnosis of histologically confirmed, locally confined, prostate adenocarcinoma and receiving definitive Intensity Modulated Radiation Therapy (IMRT) at 78 Gy (2 Gy/fraction) are enrolled in this pilot study. Ten millilitres of EDTA blood samples are obtained before radiotherapy (baseline), after a dose of 8 Gy, after 50 Gy, at radiotherapy end and one month after treatment completion. Samples are centrifuged for 20 minutes at 2200 r.c.f./4 °C and immediately stored at ≤−80°C until analysis. All analyses are carried out blind to patient and therapy factors.

The amount of IL-1b, IL-6, CXCL8, TNFalpha, CCL2 and PTX3 are determined using commercially available ELISA kits (R&D Systems Inc., Minneapolis, MN, USA), according to manufacturer's protocols.

Participants are examined at the start of treatment, once weekly during treatment, at the end of RT, and every six months thereafter till 5 year follow-up.

Radio-induced toxicity is scored using a self-administered questionnaire. It consists of 10 questions, the answers to which are worded to be compatible with a 4-point categorical scale (1, not at all; 2, a little; 3, much; and 4, very much) which correspond to the SOMA/LENT (Subjective Objective Management Analytic/Late Effects on Normal Tissue) grading. With this questionnaire, four major types of rectal injury can be evaluated: rectal bleeding and mucosal loss, sphincter control and continence, stool frequency, and pain and urgency.

Acute rectal symptoms are defined as the maximum grade reached within one month after radiotherapy end. Late symptoms are determined as the maximum grade reached between six months and five years after treatment completion.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Plasma levels of the selected inflammatory molecules in prostate cancer patients undergoing radical radiotherapy are measured using commercially available ELISA kits according to manufacturer's protocols at before radiotherapy (baseline), after a dose of 8 Gy (at the end of the first week of radiotherapy), after 50 Gy (at the end of fifth week of radiotherapy), at radiotherapy end and one month after treatment completion
2. Levels of inflammatory molecule kinetics as a function of radiation dose and follow-up time are measured using commercially available ELISA kits at timepoints are before radiotherapy (baseline), after a dose of 8 Gy (at the end of the first week of radiotherapy), after 50 Gy (at the end of fifth week of radiotherapy), at radiotherapy end and one month after treatment completion

Secondary outcome measures

1. Relationship between plasma levels of the selected inflammatory molecules and acute/late radioinduced intestinal toxicity. Plasma levels of the selected inflammatory molecules in prostate cancer patients undergoing radical radiotherapy. They are measured using commercially available ELISA kits (R&D Systems Inc., Minneapolis, MN, USA), according to manufacturer's protocols. Considered timepoints are before radiotherapy (baseline), after a dose of 8 Gy (at the end of the first week of radiotherapy), after 50 Gy (at the end of fifth week of radiotherapy), at radiotherapy end and one month after treatment completion.
2. Scoring of acute and late intestinal toxicity, patients are examined at the start of treatment, once weekly during treatment, at the end of RT, and every six months thereafter till 5 year follow-up. Radio-induced toxicity is scored using a self-administered questionnaire.

Overall trial start date

01/12/2010

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Prostate cancer patient
2. Radical radiotherapy treatment at doses>74 Gy, standard fractionation at 2Gy/fraction, 1 fraction/day, 5 days/week
3. Three-dimensional conformal radiotherapy or Intensity Modulated radiotherapy
4. Age >=18 years and age <=80 years
5. Written informed consent
6. Availability for blood sample before radiotherapy (baseline), after a dose of 8 Gy, after 50 Gy, at radiotherapy end and one month after treatment completion

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Age <18 years and age >80 years
2. Previous radiotherapy in pelvic or abdomen region
3. Patients with infections at time of possible enrollment
4. Patients with chronic inflammatory bowel diseases
5. Patients chronically treated with cortisonic drugs, non-steroid antiinflamatory drugs, or with immunosuppressive therapies
6. Patients who cannot guarantee adequate follow-up

Recruitment start date

04/03/2011

Recruitment end date

02/07/2012

Locations

Countries of recruitment

Italy

Trial participating centre

Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
20133
Italy

Sponsor information

Organisation

Fondazione IRCCS Istituto Nazionale dei Tumori

Sponsor details

Via Venezian 1
Milan
20133
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Fondazione IRCCS Istituto Nazionale dei Tumori

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication is planned in a high-impact peer reviewed journal within end of 2018.

IPD sharing statement:
The dataset is not available as we did not foresee this while having ethics approval. Patients signed a consent on treatment of their data where it was stated that data would be kept inside the National Cancer Institute. Data are held on a server in electronic format and in paper sheets at the National Cancer Institute in Milan.

Intention to publish date

01/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes