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

University Medical Center Groningen10,000 enrolled

Overview

The goal is to gain insight in the development and course of the toxicity after a curative treatment of prostate cancer

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.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

2. Change in patient -rated Quality-of-Life

Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function

Time frame: First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT

Central Contacts

S. Aluwini, MD PhD

CONTACT

+31503612346 s.al-uwini@umcg.nl

P. Veldhuijzen van Zanten

CONTACT

+31503614659 p.veldhuijzen@umcg.nl

Data from ClinicalTrials.gov

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