Hypofractionated Stereotactic Boost in Prostate Cancer (CKNO-PRO)
This study is currently recruiting participants.
Verified May 2012 by Centre Oscar Lambret
Sponsor:
Centre Oscar Lambret
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01596816
First received: June 15, 2011
Last updated: May 9, 2012
Last verified: May 2012
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Purpose
The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Radiation: First part of treatment : Conformal irradiation Procedure: Fiducials placement Radiation: Second part : hypofractionated stereotactic boost |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study |
Resource links provided by NLM:
Further study details as provided by Centre Oscar Lambret:
Primary Outcome Measures:
- Change from baseline in rectal functions [ Time Frame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years ] [ Designated as safety issue: Yes ]
- Assessment of rectal toxicity according to the NCI-CTCAE v4.0 scale.
- Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
- Change from baseline in urinary function. [ Time Frame: Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years ] [ Designated as safety issue: Yes ]
- Assessment of urinary toxicity according to the NCI-CTCAE v4.0 scale.
- Acute toxicities are defined as all toxicities occurring within 6 months after the start of radiotherapy, late toxicities are those that occur beyond this period.
Secondary Outcome Measures:
- Local control of prostate cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Local control is defined as:
- Non progressive PSA according to Phoenix criteria
- Non progressive clinical examination (DRE)
- No pathological findings on MRI
- Global and metastase-free survival [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]Time measurement between the inclusion and the date of death/metastatic progression
- PSA kinetics [ Time Frame: Between radiotherapy and boost, and after treatment : every 3 months ] [ Designated as safety issue: No ]Comparison of the PSA dosage before, at the end of treatment then every 3 months. The PSA dosage evolution will be correlate with the local control treatment.
- Sexual toxicity [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]According to IIEF5 questionnaire ( International Index of Erectile Function )
- Technical criteria : Fiducial placement (yes/no) [ Time Frame: During the time of treatment ] [ Designated as safety issue: No ]
- Urinary discomfort [ Time Frame: Up to 5 years after treatment ] [ Designated as safety issue: No ]According to IPSS questionnaire ( International Prostate Symptom Score)
- Technical criteria : Cumulative dosimetry (1 time/ 2 times) [ Time Frame: During the time of treatment ] [ Designated as safety issue: No ]
- Technical criteria : boost schedule (yes/no) [ Time Frame: During the time of treatment ] [ Designated as safety issue: No ]
- Technical criteria : duration of boost [ Time Frame: During the treatment ] [ Designated as safety issue: No ]Time between patient's entry and exit of the radiotherapy treatment room
| Estimated Enrollment: | 76 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Boost by CyberKnife |
Radiation: First part of treatment : Conformal irradiation
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Procedure: Fiducials placement
Placement of intra-prostatic markers for the tracking
Radiation: Second part : hypofractionated stereotactic boost
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
|
| Experimental: Boost by linear accelerator |
Radiation: First part of treatment : Conformal irradiation
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
Procedure: Fiducials placement
Placement of intra-prostatic markers for the tracking
Radiation: Second part : hypofractionated stereotactic boost
3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Prostate adenocarcinoma proved by histology
With at least one of this intermediate-risk criterias:
- T2b
- and/or PSA between 10 et 20 ng/ml
- and/or Gleason score = 7
- Prostatic volume ≤ 80 cc
- No adenopathy(lymph node < 1.5 cm on scanner or MRI and/or in lymph node dissection)
- No metastasis (bone scan)
- Age >= 18 ans
- No prior pelvic irradiation
- No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy > 3 months)
- Performance status (ECOG) < 1
- No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation
- Life expectancy >= 10 weeks
- Patient affiliated to health insurance
- Informed consent signed by the patient
Exclusion Criteria:
- Cancer no histologically proved
- Unfavorable-risk(T2c and/or PSA > 20 ng/ml and/or Gleason > 7)
- Favorable-risk(T1c T2a and PSA < 10 ng/ml and Gleason < 7)
- T3 and T4
- History of cancer uncontrolled and/or treated since less of 5 years (except basal cell carcinoma of the skin)
- Contraindication to MRI
- IPSS score > 10
- Recurrent or metastatic disease
- Allergy to gold
- Patient already included in another therapeutic trial with an experimental molecule
- Unable for medical follow-up (geographic, social or mental reasons)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596816
Contacts
| Contact: Eric LARTIGAU, PhD | 03 20 29 59 18 | e-lartigau@o-lambret.fr |
| Contact: Yvette VENDEL, Sponsor CRA | (33)3 20 29 59 40 | y-vendel@o-lambret.fr |
Locations
| France | |
| Centre Paul Papin | Recruiting |
| Angers, France, 49933 | |
| Contact: Patrice CELLIER, MD 02 41 35 28 81 p.cellier@unimedia.fr | |
| Sub-Investigator: Nathalie NEBOUT, MD | |
| Sub-Investigator: Clothilde MORAND, MD | |
| Sub-Investigator: Delphine JARNET, MD | |
| Sub-Investigator: Jérôme MESGOUEZ, MD | |
| Principal Investigator: Patrice CELLIER, MD | |
| Centre Georges François Leclerc | Recruiting |
| Dijon, France, 21079 | |
| Contact: Philippe MAINGON, MD, PhD 03 80 73 75 17 pmaingon@dijon.fnclcc.fr | |
| Sub-Investigator: Gilles CREHANGE, MD | |
| Sub-Investigator: Etienne MARTIN, MD | |
| Sub-Investigator: Suzanne NAUDY, MD | |
| Principal Investigator: Philippe MAINGON, MD, PhD | |
| Centre Oscar LAMBRET | Recruiting |
| Lille, France, 59020 | |
| Contact: Eric LARTIGAU, MD, PhD 03 20 29 59 18 e-lartigau@o-lambret.fr | |
| Sub-Investigator: Philippe NICKERS, MD, PhD | |
| Sub-Investigator: Thomas LACORNERIE, MD | |
| Sub-Investigator: Thierry SARRAZIN, MD | |
| Principal Investigator: Eric LARTIGAU, MD, PhD | |
| Centre Léon Bérard | Recruiting |
| Lyon, France, 69373 | |
| Contact: Pascal POMMIER, MD 04 78 78 51 66 pommier@lyon.fnclcc.fr | |
| Sub-Investigator: Christian CARRIE, MD | |
| Sub-Investigator: Frédéric GASSA, MD | |
| Principal Investigator: Pascal POMMIER, MD, PhD | |
| Val d'Aurelle-Paul Lamarque | Recruiting |
| Montpellier, France, 34298 | |
| Contact: David AZRIA, MD 04 67 61 31 32 azria@valdorel.fnclcc.fr | |
| Sub-Investigator: Carmen LLACER MOSCARDO, MD | |
| Sub-Investigator: Norbert AILLERES, MD | |
| Principal Investigator: David AZRIA, MD | |
| Centre Hospitalier Lyon Sud | Recruiting |
| Pierre Benite, France, 69310 | |
| Contact: Olivier CHAPET, MD, PhD 04 78 86 42 60 olivier.chapet@chu-lyon.fr | |
| Sub-Investigator: Patrice JALADE, MD | |
| Principal Investigator: Olivier CHAPET, MD, PhD | |
| Centre Alexis Vautrin | Recruiting |
| Vandoeuvre Les Nancy, France, 54500 | |
| Contact: Didier PEIFFERT, PhD 03 83 59 84 31 d.peiffert@nancy.fnclcc.fr | |
| Sub-Investigator: Véronique BECKENDORF, MD | |
| Sub-Investigator: Alain NOEL, MD | |
| Sub-Investigator: Vincent MARCHESI, MD | |
| Principal Investigator: Didier PEIFFERT, MD, PhD | |
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
| Principal Investigator: | Eric LARTIGAU, MD, PhD | Centre Oscar Lambret |
More Information
No publications provided
| Responsible Party: | Centre Oscar Lambret |
| ClinicalTrials.gov Identifier: | NCT01596816 History of Changes |
| Other Study ID Numbers: | CKNO-PRO-0901 |
| Study First Received: | June 15, 2011 |
| Last Updated: | May 9, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Oscar Lambret:
|
prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013