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

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT03034187
• Lead Sponsor: University Medical Center Groningen

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-04
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2025-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10000

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in Acute toxicity	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 Outcome Measures

Name	Time	Method
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	Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands