Prostate CancerNCT03162523
Experiences With HDR-brachytherapy in Norway
An observational study of Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
There are 3 articles that will be written about the experience with HDR-brachytherapy (HDR-BT) in patients with high-risk prostate cancer in Norway as part of a doctorial thesis-project. The project will focus on survival, side-effects and dosimetry variables as the main points of interest. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High-Dose Rate Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 325 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to 15 Oct 2016
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men are included from the south-east area of Norway and for control Groups from the entire country so that the study population is generalised.
Who may be able to join
- age, high-risk prostate cancer, general good Health, anatomical favourable condition for brachytherapy
Who cannot join
- poor Health, metastasis, T3b stage tumour, Prostate Specific Antigen (PSA) Levels > 75, biological age > 75 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norwegian Experiences With Interstitial Radiation Treatment (Brachytherapy) for Men With High-risk Localised Prostate Cancer
There are 3 articles that will be written about the experience with HDR-brachytherapy (HDR-BT) in patients with high-risk prostate cancer in Norway as part of a doctorial thesis-project. The project will focus on survival, side-effects and dosimetry variables as the main points of interest.
Read the detailed description
First article will compare overall and prostate cancer specific-mortality in patients who has received HDR-BT compared to patients who has received external beam radiation therapy only (EBRT). Patients who have been treated with HDR-BT have been enrolled in an approved registry at Oslo University Hospital since 2004. The control group (EBRT only) data are from the Lancet published hallmark study SPCG-7 (Scandinavian Prostate Cancer Group). This is a case-control study.
Second article will focus on side-effects of HDR-BT compared to EBRT patients. Patients included in the registry described above have been sent (and completed with a 72% answer rate) a questionnaire of the standard Expanded Prostate Cancer Index (EPIC-26) form. This will be compared to patients who already have answered the same questionnaire in a previously published study (approved by the Norwegian Ethical Committee).
The Third article will investigate if there are any association between patients reporting severe adverse effects after HDR-BT and the patients dosimetry reports (i.e are there a larger dose to the urethra or rectum in these patients?)
- Conditions
- Prostate Cancer
- Being tested
- High-Dose Rate Brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Rate BrachytherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Scandinavian Prostate Cancer Group (SPCG), study number 7 | Patients included in hallmark study of SPCG-7 receiving EBRT to 70 Gy in combination with lifelong anti-androgen treatment Receives: Radiation: High-Dose Rate Brachytherapy | |
| Norwegian Urologic Cancer Group (NUCG) study number 7 | Patients receiving EBRT to 74 Gy in combination with hormonal therapy. Approved by ethical comittee. Questionnaires already been completed during a different study (NUCG-7). These patients will therefore not be contacted again. Receives: Radiation: High-Dose Rate Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall- and Prostate-Cancer specific mortality in patients treated with HDR-BT compared to EBRT alone
The final measured outcome is death by prostate cancer, death due to other cause (overall mortality) or alive at 10 years.
Measured: 24 weeks
Patient-reported side-effects after HDR-BT compared to conventional EBRT
Patient self-reported side-effects focusing on rectal, bladder, quality of life, sexual function and psycological bother will be recorded in both Groups and compared.
Measured: 1 year
Are there an Association between rectal dosage after HDR-BT and self-reported rectal bother in patients undergone HDR-BT treatment ?
Investigations into needle placement, dosage and anatomical variations will be examined in patients who report rectal problems 5 years after HDR-BT treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startJan 2004
- Primary completion15 Oct 2016
- Study completion15 Oct 2016
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 Oslo University HospitalThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 325 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Trude Baastad Wedde, Oslo University Hospital
- Investigators
- Trude Wedde, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162523
- Sponsor's protocol ID
- 677905
- Status last verified
- May 2017
- First submitted
- 7 May 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Experiences With Interstitial Radiation Treatment (Brachytherapy) for Men With High-risk Localised Prostate Cancer
- ClinicalTrials.gov ID
- NCT03162523
- Acronym / sponsor ID
- 677905
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jan 2004 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 15 Oct 2016 (actual)
- First posted
- 22 May 2017 (actual)
- 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.
There are 3 articles that will be written about the experience with HDR-brachytherapy (HDR-BT) in patients with high-risk prostate cancer in Norway as part of a doctorial thesis-project. The project will focus on survival, side-effects and dosimetry variables as the main points of interest.
Detailed description
First article will compare overall and prostate cancer specific-mortality in patients who has received HDR-BT compared to patients who has received external beam radiation therapy only (EBRT). Patients who have been treated with HDR-BT have been enrolled in an approved registry at Oslo University Hospital since 2004. The control group (EBRT only) data are from the Lancet published hallmark study SPCG-7 (Scandinavian Prostate Cancer Group). This is a case-control study.
Second article will focus on side-effects of HDR-BT compared to EBRT patients. Patients included in the registry described above have been sent (and completed with a 72% answer rate) a questionnaire of the standard Expanded Prostate Cancer Index (EPIC-26) form. This will be compared to patients who already have answered the same questionnaire in a previously published study (approved by the Norwegian Ethical Committee).
The Third article will investigate if there are any association between patients reporting severe adverse effects after HDR-BT and the patients dosimetry reports (i.e are there a larger dose to the urethra or rectum in these patients?)
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scandinavian Prostate Cancer Group (SPCG), study number 7 | – | Radiation: High-Dose Rate BrachytherapyPatients included in hallmark study of SPCG-7 receiving EBRT to 70 Gy in combination with lifelong anti-androgen treatment |
| Norwegian Urologic Cancer Group (NUCG) study number 7 | – | Radiation: High-Dose Rate BrachytherapyPatients receiving EBRT to 74 Gy in combination with hormonal therapy. Approved by ethical comittee. Questionnaires already been completed during a different study (NUCG-7). These patients will therefore not be contacted again. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men are included from the south-east area of Norway and for control Groups from the entire country so that the study population is generalised.
Key inclusion criteria (1 listed)
- age, high-risk prostate cancer, general good Health, anatomical favourable condition for brachytherapy
Key exclusion criteria (1 listed)
- poor Health, metastasis, T3b stage tumour, Prostate Specific Antigen (PSA) Levels > 75, biological age > 75 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Dose Rate Brachytherapy | Radiation | Norwegian Urologic Cancer Group (NUCG) study number 7, Scandinavian Prostate Cancer Group (SPCG), study number 7 |
Primary outcome
Overall- and Prostate-Cancer specific mortality in patients treated with HDR-BT compared to EBRT alone
Time frame: 24 weeks
The final measured outcome is death by prostate cancer, death due to other cause (overall mortality) or alive at 10 years.
Patient-reported side-effects after HDR-BT compared to conventional EBRT
Time frame: 1 year
Patient self-reported side-effects focusing on rectal, bladder, quality of life, sexual function and psycological bother will be recorded in both Groups and compared.
Are there an Association between rectal dosage after HDR-BT and self-reported rectal bother in patients undergone HDR-BT treatment ?
Time frame: 2 years
Investigations into needle placement, dosage and anatomical variations will be examined in patients who report rectal problems 5 years after HDR-BT treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Trude Wedde, MD principal investigator
Oslo University Hospital
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 Oslo University Hospital at 1 site in Norway.
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 1 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: finished, as of the sponsor's last update on 25 May 2017. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall- and Prostate-Cancer specific mortality in patients treated with HDR-BT compared to EBRT alone (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 25 May 2017.