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

NCT ID: NCT03034187

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-04-30

Study Completion Date

2028-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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S. Aluwini, MD PhD

Role: CONTACT

+31503612346

P. Veldhuijzen van Zanten

Role: CONTACT

+31503614659

Facility Contacts

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A.C.M Van Den Bergh, MD PhD

Role: primary

+31503611194

Other Identifiers

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H1998-12/SFP-Prostate

Identifier Type: -

Identifier Source: org_study_id

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