Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate (SFP-PROSTATE)
Radiation Induced Toxicity in Prostate Cancer
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: S. Aluwini, MD PhD
- Phone Number: +31503612346
- Email: s.al-uwini@umcg.nl
Study Contact Backup
- Name: P. Veldhuijzen van Zanten
- Phone Number: +31503614659
- Email: p.veldhuijzen@umcg.nl
Study Locations
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Groningen, Netherlands, 9700RB
- Recruiting
- University Medical Center Groningen
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Contact:
- A.C.M Van Den Bergh, MD PhD
- Phone Number: +31503611194
- Email: a.c.m.van.den.bergh@umcg.nl
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Principal Investigator:
- A.C.M Van Den Bergh, MD PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
All with curative intent treated prostate cancer patients who will be treated with RT will be enrolled in the SFP.
It also includes the post-surgical adjuvant treatment and patients with positive lymph nodes to research the development and toxicity after RT
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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
Time Frame: First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
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Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function
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First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3. Change in physiological parameters
Time Frame: First visit/2 months after RT/1, 2, 3, 4, 5 years after RT
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PSA and Testosteron
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First visit/2 months after RT/1, 2, 3, 4, 5 years after RT
|
|
4. Change in Acute/ Late toxicity(physician rated)
Time Frame: First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
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Common Terminology Criteria for Adverse Events, version 4.0
|
First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1998-12/SFP-Prostate
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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