To Evaluate the Rate of Digestive and Urinary ToxicitySHORTNCT03417336
Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk
A study testing prostatic boost in brachytherapy with high dose rate (HDR) in people with To Evaluate the Rate of Digestive and Urinary Toxicity, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial summary
The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- To Evaluate the Rate of Digestive and Urinary Toxicity
- What is being tested?
- prostatic boost in brachytherapy with high dose rate (HDR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Jan 2018to 24 Apr 2029
- Phase
- Interventional
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of the prostate
- Patient with one of the following cases:
- Gleason 7 - 10 + T1c - T2b + PSA < 50 ng/mL or
- Gleason 6 + T2c - T4 ou envahissement ≥ 50% sur les biopsies + PSA < 50 ng/mL or
- Gleason 6 + T1c - T2b + PSA > 20 ng/mL
- Risk of lymph node involvement> 15%
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- Patient N0, or Nx
- Prostate volume estimated on MRI or ultrasound less than 60 cc.
- Absence of pelvic lymphadenopathy ≥ 15 mm on CT or MRI extension assessment
- Lack of bone and / or visceral metastasis on CT scan and bone scintigraphy
- Hormonal treatment started maximum 90 days before the beginning of the irradiation,
- IPSS score <12 without alpha blocker treatment
- Absence of prior pelvic radiotherapy,
- Lack of surgical treatment for prostate cancer except transurethral resection performed within 6 months before radiotherapy,
- Age ≥ 18 years and ≤ 85 years,
- WHO performance index ≤ 1,
- Estimated life expectancy> 5 years,
- Indication of treatment with radiotherapy and validated hormone therapy in a multidisciplinary consultation meeting
- Affiliation to a social security scheme,
- Signed informed consent.
Who cannot join
- Prostate cancer of histology other than adenocarcinoma,
- Patient diagnosed with N1 during imaging or pN1,
- serum PSA level> 100 ng / ml,
- IPSS score ≥ 12 or alpha blocker treatment,
- Prostate volume estimated on MRI or ultrasound> 60 cc
- History of cancer in the 5 years prior to entry into the trial,
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- History of trans-urethral resection of prostate less than 6 months old,
- History of rectal surgery,
- History of pelvic irradiation,
- Patient with severe hypertension not controlled by appropriate treatment,
- Contraindication to pelvic irradiation,
- Patient not eligible for brachytherapy
- Prostate volume> 60cc
- Urine flow measurement with max flow <12 mL / s
- Or curative anticoagulant treatment
- Or contraindication to general anesthesia
- Patient treated with antineoplastic or drug may include methotrexate,
- Hormone therapy started> 90 days before the first irradiation,
- Patient on immunosuppressant therapy
- Contraindication to agonists or antagonists of LHRH,
- Bilateral hip prosthesis,
- Patient already included in another therapeutic trial with an experimental molecule,
- Patient unable to cooperate during treatment,
- Persons deprived of their liberty or guardianship,
- Inability to undergo medical follow-up of the test.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Georges François Leclerc
Dijon, 21000
- Recruiting
CGFL
Dijon, 21079
Emilie REDERSTORFF, PhD, +33 (0)3 80 73 75 00 ext. 34 61, ERederstorff@cgfl.fr
About this study
Official title: Multicenter, Randomized, Pilot Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost (Stereotaxic External Radiotherapy or High Dose Rate Brachytherapy) in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk
The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years.
Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments. This therapeutic scheme makes it possible to deliver a higher equivalent biological dose than during a treatment carried out with a conventional fractionation.
Read more
The results with a follow-up of 9 years are extremely encouraging and do not show any excess toxicity compared to other irradiation techniques. They confirm that urinary and digestive toxicities are acceptable. All these studies did not involve pelvic irradiation. Several trials have also demonstrated the feasibility of normofractionated pelvic irradiation associated with hypofractionated prostatic irradiation using an integrated boost technique.
The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:
- a prostatic boost in brachytherapy with high dose rate (HDR) or
- an integrated boost in stereotaxis (in case of contraindication to brachytherapy)
- Being tested
- prostatic boost in brachytherapy with high dose rate (HDR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostatic boost in brachytherapy with high dose rate (HDR)Radiation
prostatic boost in brachytherapy with high dose rate (HDR)
| Study group | Role | What they receive |
|---|---|---|
| brachytherapy + External radiotherapy | Experimental | Prostate booster, HDR brachytherapy with 15Gy in 1 fraction + external radiotherapy 25Gy in 5 fractions Receives: Radiation: prostatic boost in brachytherapy with high dose rate (HDR) |
| External radiotherapy | Active comparator | Exclusive external radiotherapy. 25Gy in 5 fractions + a 40Gy prostate boost in stereotaxic conditions. Receives: Radiation: prostatic boost in brachytherapy with high dose rate (HDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of digestive and urinary toxicity accumulated at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start24 Jan 2018
- Primary completion24 Apr 2029 (estimated)
- Study completion24 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Rate of Digestive and Urinary ToxicityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417336
- Sponsor's protocol ID
- 2017-A00042-51
- Acronym
- SHORT
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2017
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Pilot Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost (Stereotaxic External Radiotherapy or High Dose Rate Brachytherapy) in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk
- ClinicalTrials.gov ID
- NCT03417336
- Acronym / sponsor ID
- SHORT / 2017-A00042-51
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 24 Apr 2029 (estimated)
- Study completion
- 24 Apr 2029 (estimated)
- First posted
- 31 Jan 2018 (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.
The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years.
Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments. This therapeutic scheme makes it possible to deliver a higher equivalent biological dose than during a treatment carried out with a conventional fractionation.
The results with a follow-up of 9 years are extremely encouraging and do not show any excess toxicity compared to other irradiation techniques. They confirm that urinary and digestive toxicities are acceptable. All these studies did not involve pelvic irradiation. Several trials have also demonstrated the feasibility of normofractionated pelvic irradiation associated with hypofractionated prostatic irradiation using an integrated boost technique.
The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:
- a prostatic boost in brachytherapy with high dose rate (HDR) or
- an integrated boost in stereotaxis (in case of contraindication to brachytherapy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brachytherapy + External radiotherapy | Experimental | Radiation: prostatic boost in brachytherapy with high dose rate (HDR)Prostate booster, HDR brachytherapy with 15Gy in 1 fraction + external radiotherapy 25Gy in 5 fractions |
| External radiotherapy | Active comparator | Radiation: prostatic boost in brachytherapy with high dose rate (HDR)Exclusive external radiotherapy. 25Gy in 5 fractions + a 40Gy prostate boost in stereotaxic conditions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adenocarcinoma of the prostate
- Patient with one of the following cases:
- Risk of lymph node involvement> 15%
- Patient N0, or Nx
- Prostate volume estimated on MRI or ultrasound less than 60 cc.
Key exclusion criteria (25 listed)
- Prostate cancer of histology other than adenocarcinoma,
- Patient diagnosed with N1 during imaging or pN1,
- serum PSA level> 100 ng / ml,
- IPSS score ≥ 12 or alpha blocker treatment,
- Prostate volume estimated on MRI or ultrasound> 60 cc
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 |
|---|---|---|
| prostatic boost in brachytherapy with high dose rate (HDR)prostatic boost in brachytherapy with high dose rate (HDR) | Radiation | External radiotherapy, brachytherapy + External radiotherapy |
Primary outcome
The rate of digestive and urinary toxicity accumulated at 3 months
Time frame: 3 months
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 17 Feb 2025.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prostatic boost in brachytherapy with high dose rate (HDR) in people with To Evaluate the Rate of Digestive and Urinary Toxicity, run by Centre Georges Francois Leclerc at 2 sites 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 20 inclusion and 25 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Magalie QUIVRIN (03.80.73.75.00, mquivrin@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of digestive and urinary toxicity accumulated at 3 months (time frame: 3 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 17 Feb 2025.