Prostate Cancer With Intermediate RiskPhase 2CURIEBOOSTNCT01039038
Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer
A Phase 2 study testing curietherapy and radiotherapy in people with Prostate Cancer With Intermediate Risk, run by Centre Francois Baclesse at 1 site in France.
Trial summary
The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer With Intermediate Risk
- What is being tested?
- curietherapy and radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Nov 2011
- Phase
- Phase 2
- 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years and ≤ 75 years
- Life expectancy >10 years
- Localized prostatic adenocarcinoma and histologically proven
- Intermediate risk cancer(T2b or PSA between 10 and 20 or Gleason = 7(3+4) according to Amico criteria
- Metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
- OMS < 2
Show all 13Show fewer
- No previous treatment by radiotherapy and/or curietherapy
- Hormonotherapy authorized before and during the study
- Rectal or uretero-vesical pathology
- Signed informed consent
- Social security system affiliation
- Individual deprived of liberty or placed under the authority of a tutor.
- No anesthesia contraindication
Who cannot join
- Adenocarcinoma not histologically proven
- Metastases presence
- Pathological nodes presence(≥ 10 mm)
- Prior prostate endoscopic resection
- history of other malignancy except for appropriately treated superficial basal cell skin cancer
- Medical contraindications to anesthesia
- Patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
- Impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study Evaluating the Feasibility of a Dose Increase by a Boost of Curietherapy in PDR Associated With the Extern Radiotherapy in Intermediate Risk in the Prostate Cancer
The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.
- Conditions
- Prostate Cancer With Intermediate Risk
- Being tested
- curietherapy and radiotherapy
- Keywords
- prostate, curietherapy, radiotherapy, intermediate risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curietherapy and radiotherapyRadiation
boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a delivered dose by a boost of curietherapy is at least 40 Gy (D95) associated to a dose of 34 Gy for extern radiotherapy
Measured: at 5 months
Secondary outcomes (1)
Acute toxicities at month 3 after end of treatment: late toxicities, survival without biological relapse, without local relapse or metastatic evolution, feasibility of MRI use in prostatic CTV
Measured: at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer With Intermediate RiskStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039038
- Sponsor's protocol ID
- CURIEBOOST
- Acronym
- CURIEBOOST
- Status last verified
- Nov 2011
- First submitted
- 11 Dec 2009
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Feasibility of a Dose Increase by a Boost of Curietherapy in PDR Associated With the Extern Radiotherapy in Intermediate Risk in the Prostate Cancer
- ClinicalTrials.gov ID
- NCT01039038
- Acronym / sponsor ID
- CURIEBOOST / CURIEBOOST
- Conditions
- Prostate Cancer With Intermediate Risk
- Keywords
- prostate, curietherapy, radiotherapy, intermediate risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Dec 2009 (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 objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 50 years and ≤ 75 years
- Life expectancy >10 years
- Localized prostatic adenocarcinoma and histologically proven
- Intermediate risk cancer(T2b or PSA between 10 and 20 or Gleason = 7(3+4) according to Amico criteria
- Metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
Key exclusion criteria (8 listed)
- Adenocarcinoma not histologically proven
- Metastases presence
- Pathological nodes presence(≥ 10 mm)
- Prior prostate endoscopic resection
- history of other malignancy except for appropriately treated superficial basal cell skin cancer
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 |
|---|---|---|
| curietherapy and radiotherapyboost of curietherapy(40 Gy)and external radiotherapy (34 Gy) | Radiation | – |
Primary outcome
Proportion of patients with a delivered dose by a boost of curietherapy is at least 40 Gy (D95) associated to a dose of 34 Gy for extern radiotherapy
Time frame: at 5 months
1 secondary outcome
Acute toxicities at month 3 after end of treatment: late toxicities, survival without biological relapse, without local relapse or metastatic evolution, feasibility of MRI use in prostatic CTV
Time frame: at 5 months
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing curietherapy and radiotherapy in people with Prostate Cancer With Intermediate Risk, run by Centre Francois Baclesse at 1 site in France.
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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Nov 2011. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Proportion of patients with a delivered dose by a boost of curietherapy is at least 40 Gy (D95) associated to a dose of 34 Gy for extern radiotherapy (time frame: at 5 months). 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 28 Nov 2011.