Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate

Study Overview
=================
Brief Summary
-----------------
The goal is to gain insight in the development and course of the toxicity after a curative treatment of prostate cancer

Detailed Description
-----------------
All with curative intent treated prostate cancer patients will be enrolled in the SFP (Standard Follow-up Programme). It also includes the post -operative adjuvant treatments and the patients with positive lymph nodes. Patients will complete weekly questionnaires to score the patient -rated toxicity. Biweekly patients are seen by the treating radiation oncologist and / or AIOS in which the physician -rated toxicity is scored. In the follow-up will always patient -rated toxicity and physician -rated toxicity can be determined. Use of an SFP should yield a profit for the practitioner , such as the automatic generation of letters. This should apply to all SFPs . Quality of life and toxicity in patients will be completed on the touch-screen computers at FU visits.

Official Title
-----------------
Radiation Induced Toxicity in Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All curative treated patients with prostatecancer( with positive lymph nodes) All patients who will be treated with RT( including post-operative, adjuvant treatments) Are willing to fill in toxicity and QOL-questionnarys (QLQ-PR25 en de QLQ-C30) Exclusion Criteria: Patients who are not willing to fill in toxicity and QOL-questionnarys Patients who will not get RT Non-curative or palliative treated patients (with bone mestasis) Non-prostate cancer-patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Change in Acute toxicity | Common Terminology Criteria for Adverse Events, version 4.0 CTCAE 4.0 Constipation CTCAE 4.0 Diarrhea CTCAE 4.0 Fecal Incontinence CTCAE 4.0 Flatulance CTCAE 4.0 Proctitis CTCAE 4.0 Rectal Hemorrhage CTCAE 4.0 Rectal Mucositis CTCAE 4.0 Rectal Ulcer CTCAE 4.0 Bladder spasm CTCAE 4.0 Cystitis Noninfective CTCAE 4.0 Hematuria CTCAE 4.0 Urinary Frequency CTCAE 4.0 Urinary Incontinence CTCAE 4.0 Urinary retention CTCAE 4.0 Urinary tract Obstruction CTCAE 4.0 Urinary tract pain CTCAE 4.0 Urinary Urgency CTCAE 4.0 Erectile dysfunction | Toxicity:First visit/Wekely during RT, Acute Toxicity: 2-wekely and at the end of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Change in patient -rated Quality-of-Life | Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function | First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute toxicity, Late toxicity, Quality of Life since 2011(set-up SFP-prostate)