An observational study in Prostate Cancer, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by University Medical Center Groningen · Observational
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Medical Center Groningen is the lead sponsor of 625 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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
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
3. Change in physiological parameters
PSA and Testosteron
Time frame: First visit/2 months after RT/1, 2, 3, 4, 5 years after RT
4. Change in Acute/ Late toxicity(physician rated)
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: First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
Plan to share: Yes — Sharing data between physicians at the Department of Radiotherapy
No publications or documents are linked to this record.
The record gives a start of Apr 1999, a primary completion of Jan 2025 and a completion of Jan 2028. It does not say whether these dates are actual or estimated.
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