Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate (SFP-PROSTATE)

Radiation Induced Toxicity in Prostate Cancer

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

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

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

• Netherlands
  • Groningen, Netherlands, 9700RB
    • Recruiting
    • University Medical Center Groningen
    • Contact: A.C.M Van Den Bergh, MD PhD; Phone Number: +31503611194; Email: a.c.m.van.den.bergh@umcg.nl
    • Principal Investigator: A.C.M Van Den Bergh, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
3. Change in physiological parameters	PSA and Testosteron	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	First Visit/ 2 wekely/ End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimated): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Acute toxicity; Late toxicity; Quality of Life since 2011(set-up SFP-prostate)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: H1998-12/SFP-Prostate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing data between physicians at the Department of Radiotherapy