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

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ClinicalTrials.gov Identifier: NCT03034187
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Shafak Al-Uwini, University Medical Center Groningen

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

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiation Induced Toxicity in Prostate Cancer
Study Start Date : April 1999
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. 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 ]

    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 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 ]
    Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function


Other Outcome Measures:
  1. 3. Change in physiological parameters [ Time Frame: First visit/2 months after RT/1, 2, 3, 4, 5 years after RT ]
    PSA and Testosteron

  2. 4. Change in Acute/ Late toxicity(physician rated) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034187


Contacts
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Contact: S. Aluwini, MD PhD +31503612346 s.al-uwini@umcg.nl
Contact: L.W. Kors, Msc +31503617244 l.w.kors@umcg.nl

Locations
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Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: A.C.M Van Den Bergh, MD PhD    +31503611194    a.c.m.van.den.bergh@umcg.nl   
Principal Investigator: A.C.M Van Den Bergh, MD PhD         
Sponsors and Collaborators
University Medical Center Groningen

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Responsible Party: Shafak Al-Uwini, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03034187     History of Changes
Other Study ID Numbers: H1998-12/SFP-Prostate
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing data between physicians at the Department of Radiotherapy

Keywords provided by Shafak Al-Uwini, University Medical Center Groningen:
Acute toxicity
Late toxicity
Quality of Life since 2011(set-up SFP-prostate)

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases