Prostate CancerSFP-PROSTATENCT03034187
Radiation-induced Toxicity in Prostate Cancer/ Standard-Follow-Up Program Prostate
An observational study of Prostate Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The goal is to gain insight in the development and course of the toxicity after a curative treatment of prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 1999to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700RB
A.C.M Van Den Bergh, MD PhD, +31503611194, a.c.m.van.den.bergh@umcg.nl
A.C.M Van Den Bergh, MD PhD
About this study
Official title: 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
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Acute toxicity, Late toxicity, Quality of Life since 2011(set-up SFP-prostate)
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
2. Change in patient -rated Quality-of-Life
Questionnarys QLQ-PR25, QLQ-C30, International Index of Erectile Function
Measured: First visit/End of RT/ 2 months after RT/1, 2, 3, 4, 5 years after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startApr 1999
- Primary completionJan 2025 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034187
- Sponsor's protocol ID
- H1998-12/SFP-Prostate
- Acronym
- SFP-PROSTATE
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2016
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Sharing data between physicians at the Department of Radiotherapy
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Induced Toxicity in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03034187
- Acronym / sponsor ID
- SFP-PROSTATE / H1998-12/SFP-Prostate
- Conditions
- Prostate Cancer
- Keywords
- Acute toxicity, Late toxicity, Quality of Life since 2011(set-up SFP-prostate)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Apr 1999
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to gain insight in the development and course of the toxicity after a curative treatment of 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. Sharing data between physicians at the Department of Radiotherapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact S. Aluwini, MD PhD (+31503612346, s.al-uwini@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.