Prostate Cancer
Conditions
Keywords
Acute toxicity, Late toxicity, Quality of Life since 2011(set-up SFP-prostate)
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.
Interventions
None listed
Sponsors
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 3. Change in physiological parameters | First visit/2 months after RT/1, 2, 3, 4, 5 years after RT | PSA and Testosteron |
| 4. Change in Acute/ Late toxicity(physician rated) | First Visit/ 2 wekely/ 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 |
Countries
Netherlands
Contacts
Primary ContactS. Aluwini, MD PhD
Backup ContactP. Veldhuijzen van Zanten
Outcome results
None listed