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NCT Number: NCT03034187

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

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

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location status: Recruiting

Location contact

A.C.M Van Den Bergh, MD PhD

CONTACT

[email protected]

+31503611194

A.C.M Van Den Bergh, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

P. Veldhuijzen van Zanten

CONTACT

[email protected]

+31503614659

S. Aluwini, MD PhD

CONTACT

[email protected]

+31503612346

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Radiation Induced Toxicity in Prostate Cancer

Acronym: SFP-PROSTATE

Important dates

Study start
1999
Primary completion
2025
Study completion
2028
First posted
Jan 27, 2017
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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