Hypofractionated Stereotactic Boost in Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2018-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

NCT01508390

Prostate Cancer

ACTIVE_NOT_RECRUITING NA

Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer

NCT05313815

Prostate Cancer

RECRUITING NA

Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

NCT02271659

Prostate Cancer

UNKNOWN NA

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

NCT03417336

To Evaluate the Rate of Digestive and Urinary Toxicity

RECRUITING NA

Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

NCT01059513

Prostate Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Boost by CyberKnife

Group Type EXPERIMENTAL

First part of treatment : Conformal irradiation

Intervention Type RADIATION

23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy

Fiducials placement

Intervention Type PROCEDURE

Placement of intra-prostatic markers for the tracking

Second part : hypofractionated stereotactic boost

Intervention Type RADIATION

3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy

Boost by linear accelerator

Group Type EXPERIMENTAL

First part of treatment : Conformal irradiation

Intervention Type RADIATION

23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy

Fiducials placement

Intervention Type PROCEDURE

Placement of intra-prostatic markers for the tracking

Second part : hypofractionated stereotactic boost

Intervention Type RADIATION

3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

First part of treatment : Conformal irradiation

23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy

Intervention Type RADIATION

Fiducials placement

Placement of intra-prostatic markers for the tracking

Intervention Type PROCEDURE

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

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No