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

Prostate Cancer Clinical Trial

— SFP-PROSTATE  

Official title:

Radiation Induced Toxicity in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03034187
• Other study ID #: H1998-12/SFP-Prostate
• Status: Recruiting
• Start date: April 1999
• Est. completion date: January 2028

Study information

• Verified date: October 2023
• Source: University Medical Center Groningen
• Contact: S. Aluwini, MD PhD
• Phone: +31503612346
• Email: s.al-uwini[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal is to gain insight in the development and course of the toxicity after a curative treatment of prostate cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 2028
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3. Change in physiological parameters	PSA and Testosteron	First visit/2 months after RT/1, 2, 3, 4, 5 years after RT
Other	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	First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
Primary	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	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	2. Change in patient -rated Quality-of-Life	Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function	First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT