Cancer
Conditions
Keywords
prostate cancer
Brief summary
hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
Detailed description
The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).
Interventions
RADIATIONFirst part of treatment : Conformal irradiation
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
PROCEDUREFiducials placement
Placement of intra-prostatic markers for the tracking
RADIATIONSecond 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
Sponsors
Centre Oscar Lambret
National Cancer Institute, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in rectal functions | Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years | * 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. | Every 3 months after boost irradiation during 1 year and then every 6 months during 2 years | * 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
| Measure | Time frame | Description |
|---|---|---|
| Local control of prostate cancer | 3 years | 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 | Up to 5 years after treatment | Time measurement between the inclusion and the date of death/metastatic progression |
| PSA kinetics | Between radiotherapy and boost, and after treatment : every 3 months | 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 | Up to 5 years after treatment | According to IIEF5 questionnaire ( International Index of Erectile Function ) |
| Technical criteria : Fiducial placement (yes/no) | During the time of treatment | — |
| Urinary discomfort | Up to 5 years after treatment | According to IPSS questionnaire ( International Prostate Symptom Score) |
| Technical criteria : Cumulative dosimetry (1 time/ 2 times) | During the time of treatment | — |
| Technical criteria : boost schedule (yes/no) | During the time of treatment | — |
| Technical criteria : duration of boost | During the treatment | Time between patient's entry and exit of the radiotherapy treatment room |
Countries
France
Contacts
PRINCIPAL_INVESTIGATOREric LARTIGAU, MD, PhD
Centre Oscar Lambret
Outcome results
None listed