Radiation Induced Toxicity in Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University Medical Center Groningen
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- 1. Change in Acute toxicity
- Status
- Recruiting
- Last Updated
- 2 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
1. Change in Acute toxicity
Time Frame: 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
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
Secondary Outcomes
- 2. Change in patient -rated Quality-of-Life(First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT)