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
Multicenter, Randomized, Pilot Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost (Stereotaxic External Radiotherapy or High Dose Rate Brachytherapy) in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk
About This Trial
- This clinical trial is testing a much shorter course of radiation given in just five sessions, followed by an extra targeted dose directly to the prostate, to see if it is safe and effective.
- It is designed for men with localized, higher-risk prostate cancer that has not spread to distant parts of the body.
- Researchers want to find out if this condensed schedule causes fewer or manageable bladder and bowel side effects compared to traditional treatments that take several weeks.
- Before considering the study, patients should know that they will also need to take standard hormone therapy and must not have received prior radiation to the pelvic area.
More Information
- The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years.
- Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments.
- This therapeutic scheme makes it possible to deliver a higher equivalent biological dose than during a treatment carried out with a conventional fractionation.
- The results with a follow-up of 9 years are extremely encouraging and do not show any excess toxicity compared to other irradiation techniques.
- They confirm that urinary and digestive toxicities are acceptable.
- All these studies did not involve pelvic irradiation.
- Several trials have also demonstrated the feasibility of normofractionated pelvic irradiation associated with hypofractionated prostatic irradiation using an integrated boost technique.
- The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with: - a prostatic boost in brachytherapy with high dose rate (HDR) or - an integrated boost in stereotaxis (in case of contraindication to brachytherapy)
Who Can Enroll
- Age Range: 18 - 85 years
- Gender: Male
- Who This Trial is For: This clinical trial is testing a much shorter course of radiation given in just five sessions, followed by an extra targeted dose directly to the prostate, to see if it is safe and effective.
Study Details
- Start Date: January 24, 2018
- Lead Sponsor: Centre Georges Francois Leclerc
Full Eligibility Criteria
Inclusion Criteria
- Adenocarcinoma of the prostate
- Patient with one of the following cases:
- Gleason 7 - 10 + T1c - T2b + PSA < 50 ng/mL or
- Gleason 6 + T2c - T4 ou envahissement ≥ 50% sur les biopsies + PSA 20 ng/mL
- Risk of lymph node involvement> 15%
- Patient N0, or Nx
- Prostate volume estimated on MRI or ultrasound less than 60 cc.
- Absence of pelvic lymphadenopathy ≥ 15 mm on CT or MRI extension assessment
- Lack of bone and / or visceral metastasis on CT scan and bone scintigraphy
- Hormonal treatment started maximum 90 days before the beginning of the irradiation,
- IPSS score 5 years,
- Indication of treatment with radiotherapy and validated hormone therapy in a multidisciplinary consultation meeting
- Affiliation to a social security scheme,
- Signed informed consent.
Exclusion Criteria
- Prostate cancer of histology other than adenocarcinoma,
- Patient diagnosed with N1 during imaging or pN1,
- serum PSA level> 100 ng / ml,
- IPSS score ≥ 12 or alpha blocker treatment,
- Prostate volume estimated on MRI or ultrasound> 60 cc
- History of cancer in the 5 years prior to entry into the trial,
- History of trans-urethral resection of prostate less than 6 months old,
- History of rectal surgery,
- History of pelvic irradiation,
- Patient with severe hypertension not controlled by appropriate treatment,
- Contraindication to pelvic irradiation,
- Patient not eligible for brachytherapy
- Prostate volume> 60cc
- Urine flow measurement with max flow 90 days before the first irradiation,
- Patient on immunosuppressant therapy
- Contraindication to agonists or antagonists of LHRH,
- Bilateral hip prosthesis,
- Patient already included in another therapeutic trial with an experimental molecule,
- Patient unable to cooperate during treatment,
- Persons deprived of their liberty or guardianship,
- Inability to undergo medical follow-up of the test.
Treatments
- Radiation: prostatic boost in brachytherapy with high dose rate (HDR)