Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Radiation Induced Toxicity in Prostate Cancer
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT03034187 · H1998-12/SFP-Prostate