Prostate CancerPropelNCT01417676
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study
A study testing Radiation: pelvic lymph nodes with boost to prostate in people with Prostate Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation: pelvic lymph nodes with boost to prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to May 2019
- Phase
- Interventional
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adenocarcinoma
- T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1
- no distant metastases
Who cannot join
- pelvic co-morbidity such as Crohns disease or ulcerative colitis
- uncontrolled heart or lung morbidity
- prior radiation treatment of pelvic region
- age > 75 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.
- Conditions
- Prostate Cancer
- Being tested
- Radiation: pelvic lymph nodes with boost to prostate
- Keywords
- prostate cancer, locally advanced, lymph node positive, radiation therapy, morbidity, early morbidity, late morbidity
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: pelvic lymph nodes with boost to prostateRadiation
78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Experimental | Not described Receives: Radiation: Radiation: pelvic lymph nodes with boost to prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of late gastro-intestinal toxicity ≥ grade 2.
based on CTCAE v.4.0 og in-house questionnaire.
Measured: 3 years and beyond
Secondary outcomes (3)
survival
Measured: 10 years
recurrence
Measured: 10 years
Incidence of late genito-urinary toxicity ≥ grade 2.
Based on CTCAE vers. 4.0 and in-house questionnaire
Measured: 3 years and beyond
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2019
- Study completionMay 2019
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 of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital, Odense University Hospital, Vejle Hospital, Aalborg University Hospital, Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Responsible party
- Sponsor
- Investigators
- Lise N Bentzen, MD., Ph.D, Principal investigator, Aarhus University Hospital, Daproca, CIRRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417676
- Sponsor's protocol ID
- CIRRO IP080210
- Acronym
- Propel
- Status last verified
- Jun 2020
- First submitted
- 15 Aug 2011
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
- ClinicalTrials.gov ID
- NCT01417676
- Acronym / sponsor ID
- Propel / CIRRO IP080210
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, locally advanced, lymph node positive, radiation therapy, morbidity, early morbidity, late morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Herlev Hospital, Odense University Hospital, Vejle Hospital, Aalborg University Hospital, Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Study start
- Apr 2011 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 16 Aug 2011 (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.
This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.
| Arm | Type | Receives |
|---|---|---|
| Radiation | Experimental | Radiation: Radiation: pelvic lymph nodes with boost to prostate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adenocarcinoma
- T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1
- no distant metastases
Key exclusion criteria (4 listed)
- pelvic co-morbidity such as Crohns disease or ulcerative colitis
- uncontrolled heart or lung morbidity
- prior radiation treatment of pelvic region
- 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 |
|---|---|---|
| Radiation: pelvic lymph nodes with boost to prostate78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week. | Radiation | Radiation |
Primary outcome
Incidence of late gastro-intestinal toxicity ≥ grade 2.
Time frame: 3 years and beyond
based on CTCAE v.4.0 og in-house questionnaire.
3 secondary outcomes
survival
Time frame: 10 years
recurrence
Time frame: 10 years
Incidence of late genito-urinary toxicity ≥ grade 2.
Time frame: 3 years and beyond
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 1 Jul 2020.
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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.
Lise N Bentzen, MD., Ph.D principal investigator
Aarhus University Hospital, Daproca, CIRRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: pelvic lymph nodes with boost to prostate in people with Prostate Cancer, run by University of Aarhus at 1 site in Denmark.
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 4 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 1 Jul 2020. 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 Denmark. 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?
Incidence of late gastro-intestinal toxicity ≥ grade 2. (time frame: 3 years and beyond). 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 1 Jul 2020.