Overview

This trial is active, not recruiting.

Condition cancer
Treatments first part of treatment : conformal irradiation, fiducials placement, second part : hypofractionated stereotactic boost
Phase phase 2
Sponsor Centre Oscar Lambret
Collaborator INCa (PHRC 2010)
Start date August 2010
End date September 2013
Trial size 76 participants
Trial identifier NCT01596816, 2010-A00237-32, CKNO-PRO-0901

Summary

The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
first part of treatment : conformal irradiation
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
fiducials placement
Placement of intra-prostatic markers for the tracking
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)
first part of treatment : conformal irradiation
23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
fiducials placement
Placement of intra-prostatic markers for the tracking
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

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
Local control of prostate cancer
time frame: 3 years
Global and metastase-free survival
time frame: Up to 5 years after treatment
PSA kinetics
time frame: Between radiotherapy and boost, and after treatment : every 3 months
Sexual toxicity
time frame: Up to 5 years after treatment
Technical criteria : Fiducial placement (yes/no)
time frame: During the time of treatment
Urinary discomfort
time frame: Up to 5 years after treatment
Technical criteria : Cumulative dosimetry (1 time/ 2 times)
time frame: During the time of treatment
Technical criteria : boost schedule (yes/no)
time frame: During the time of treatment
Technical criteria : duration of boost
time frame: During the treatment

Eligibility Criteria

Male participants at least 18 years old.

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)

Additional Information

Official title Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study
Principal investigator Eric LARTIGAU, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.