Prostate CancerPhase 2TARGETNCT01148069
Surgery Combined With Intensity Modulated Radiation Therapy - Image-Guided Radiation Therapy (IMRT-IGRT) in Locally-advanced Prostate Cancers
A Phase 2 study testing Surgery combined with IMRT-IGRT in people with Prostate Cancer and Prostate Adenocarcinoma, run by Rennes University Hospital at 2 sites in France.
Trial summary
Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Surgery combined with IMRT-IGRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jul 2010to 4 Jul 2018
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18,
- Prostate adenocarcinoma (histologically proven),
- Locally-advanced (T3a or Gleason > 7 or PSA ≥ 20 ng/mL),
- Distal half of seminal vesicles unaffected on MRI,
- Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy),
- Radiotherapy and hormonotherapy indication,
Show all 16Show fewer
- Medical insurance affiliation,
- Written informed consent.
- Non-inclusion criteria:
- Co-morbidity or medical history contraindicating surgery (pelvic lymphadenectomy and seminal vesicle ablation),
- Contraindication to pelvic irradiation,
- Hip prosthesis,
- History of cancer for the last 5 years (except baso-cellular epithelioma),
- History of pelvic irradiation,
- Person deprived of freedom or under guardianship,
- Participation in another biomedical research.
Who cannot join
- Surgery showing lymph nodes involvement (pelvic radiation indication)
- Surgery without ablation of seminal vesicles
- Surgery with positive margins in seminal vesicles
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Urologie - Hôpital de Pontchaillou
Rennes, 35033
Centre Eugène Marquis - CRLCC
Rennes, 35042
About this study
Official title: Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers
Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:
- pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV);
- a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).
Read the detailed description
This study targets non metastatic prostatic locally-advanced adenocarcinomas which are at high risk of both local progression and metastases. The standard treatment of these tumours associates external beam radiation therapy (EBRT) and 3 years of androgen deprivation (AD) with LH-RH analogue. In the absence of AD and mainly when prostate specific antigen (PSA) is >10 ng/ml, several randomized studies have shown that high doses of EBRT increase biochemical control. Nevertheless, escalating the doses of radiation significantly increases the risk of rectal and/or urinary toxicities. In order to lower the toxicity of irradiation in locally-advanced prostate cancers, and to improve the quality of life of patients, this study aims at decreasing the volume of irradiated healthy tissues. To carry out this objective, we will use a double strategy:
- Limiting the target volume to prostate only by removing seminal vesicles at the time of lymph node dissection,
- Using a technique of high-precision radiation combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).
Based on the literature, we may assume a toxicity rate of 30% during the three years of hormonotherapy with standard treatment (i.e. without removing seminal vesicles). We make the hypothesis of a 20% absolute reduction of toxicity with our protocol.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Surgery combined with IMRT-IGRT
- Keywords
- IMRT-IGRT, radiotherapy toxicity, seminal vesicles
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery combined with IMRT-IGRTProcedure or surgery
Patients will have surgery consisting in extensive pelvic dissection and ablation of seminal vesicles. Surgery will be followed by prolonged hormonotherapy (3 years) associated, after 2 months, with prostatic only irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Surgery combined with IMRT-IGRT | Experimental | Not described Receives: Procedure: Surgery combined with IMRT-IGRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity)
Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed between 6 months and 3 years after the beginning of the radiotherapy.
Measured: between 6 months and 3 years
Secondary outcomes (7)
Dose received by the rectum and the bladder with and without seminal vesicles irradiation
Assessed using a dose-volume histogram
Measured: Before treatment
Quality of life
Assessed with EORTC questionnaires (QLQ-C30, QLQ-PR25)
Measured: 3 years
Erectile troubles
Assessed with erectile troubles questionnaire (IIEF-5)
Measured: 3 years
Onset of biological signs evocating a recidive
Assessed with PSA levels
Measured: 3 years
Onset of clinical signs evocating a recidive
Measured: 3 years
Specific and global survival
Measured: 3 years
Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) (early toxicity)
Rate of late bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed 6 months after the beginning of the radiotherapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start30 Jul 2010
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
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 Rennes 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center Eugene Marquis
- Responsible party
- Sponsor
- Investigators
- Renaud DE CREVOISIER, MD, PhD, Principal investigator, Rennes CRLCC Eugène MarquisSebastien VINCENDEAU, MD, Study director, Rennes University HospitalEric BELLISSANT, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148069
- Sponsor's protocol ID
- ID RCB 2009-A01336-51
- Other IDs
- LOC/09-07, CIC0203/128
- Acronym
- TARGET
- Status last verified
- Dec 2018
- First submitted
- 18 Jun 2010
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers
- ClinicalTrials.gov ID
- NCT01148069
- Acronym / sponsor ID
- TARGET / ID RCB 2009-A01336-51
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- IMRT-IGRT, radiotherapy toxicity, seminal vesicles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Center Eugene Marquis
- Study start
- 30 Jul 2010 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 22 Jun 2010 (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.
Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:
- pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV);
- a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).
Detailed description
This study targets non metastatic prostatic locally-advanced adenocarcinomas which are at high risk of both local progression and metastases. The standard treatment of these tumours associates external beam radiation therapy (EBRT) and 3 years of androgen deprivation (AD) with LH-RH analogue. In the absence of AD and mainly when prostate specific antigen (PSA) is >10 ng/ml, several randomized studies have shown that high doses of EBRT increase biochemical control. Nevertheless, escalating the doses of radiation significantly increases the risk of rectal and/or urinary toxicities. In order to lower the toxicity of irradiation in locally-advanced prostate cancers, and to improve the quality of life of patients, this study aims at decreasing the volume of irradiated healthy tissues. To carry out this objective, we will use a double strategy:
- Limiting the target volume to prostate only by removing seminal vesicles at the time of lymph node dissection,
- Using a technique of high-precision radiation combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).
Based on the literature, we may assume a toxicity rate of 30% during the three years of hormonotherapy with standard treatment (i.e. without removing seminal vesicles). We make the hypothesis of a 20% absolute reduction of toxicity with our protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery combined with IMRT-IGRT | Experimental | Procedure: Surgery combined with IMRT-IGRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age > 18,
- Prostate adenocarcinoma (histologically proven),
- Locally-advanced (T3a or Gleason > 7 or PSA ≥ 20 ng/mL),
- Distal half of seminal vesicles unaffected on MRI,
- Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy),
Key exclusion criteria (3 listed)
- Surgery showing lymph nodes involvement (pelvic radiation indication)
- Surgery without ablation of seminal vesicles
- Surgery with positive margins in seminal vesicles
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 |
|---|---|---|
| Surgery combined with IMRT-IGRTPatients will have surgery consisting in extensive pelvic dissection and ablation of seminal vesicles. Surgery will be followed by prolonged hormonotherapy (3 years) associated, after 2 months, with prostatic only irradiation. | Procedure or surgery | Surgery combined with IMRT-IGRT |
Primary outcome
Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity)
Time frame: between 6 months and 3 years
Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) observed between 6 months and 3 years after the beginning of the radiotherapy.
7 secondary outcomes
Dose received by the rectum and the bladder with and without seminal vesicles irradiation
Time frame: Before treatment
Quality of life
Time frame: 3 years
Erectile troubles
Time frame: 3 years
Onset of biological signs evocating a recidive
Time frame: 3 years
Onset of clinical signs evocating a recidive
Time frame: 3 years
Specific and global survival
Time frame: 3 years
Rate of bladder and/or rectal grade ≥2 toxicity (CTCAE V4.0) (early toxicity)
Time frame: 6 months
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 19 Dec 2018.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Renaud DE CREVOISIER, MD, PhD principal investigator
Rennes CRLCC Eugène Marquis
Sebastien VINCENDEAU, MD study director
Rennes University Hospital
Eric BELLISSANT, MD, PhD study chair
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgery combined with IMRT-IGRT in people with Prostate Cancer and Prostate Adenocarcinoma, run by Rennes University Hospital 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 16 inclusion and 3 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 19 Dec 2018. 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.
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 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?
Rate of bladder and/or rectal grade ≥2 toxicity (late toxicity) (time frame: between 6 months and 3 years). 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 19 Dec 2018.