Cytokine levels during prostate cancer radiotherapy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN64979094

Enrollment

Registered

2017-12-14

Start date

2011-03-04

Completion date

Unknown

Last updated

2019-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Prostate cancer

Interventions

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 enro

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

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026