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

Launched by CENTRE GEORGES FRANCOIS LECLERC · Jan 24, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat patients with high-risk prostate cancer, specifically looking at how well a special type of radiation therapy works and how it affects patients’ digestive and urinary health. The treatment involves giving radiation to the prostate and pelvic area in five sessions, followed by a boost of radiation directly to the prostate. The goal is to see if this method causes any side effects related to digestion and urination over the first three months after treatment.

To be eligible for this trial, participants must be adult men aged 18 to 85 diagnosed with prostate adenocarcinoma (a type of prostate cancer) and meet certain health criteria, such as having a specific score indicating the severity of their cancer and no prior pelvic radiation treatment. Participants can expect to receive the radiation treatment and will be monitored for any side effects. This trial is currently recruiting participants, and it aims to provide valuable information on a treatment that may be more effective with less toxicity compared to traditional methods.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Adenocarcinoma of the prostate
• 2. 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 \< 50 ng/mL or
• • Gleason 6 + T1c - T2b + PSA \> 20 ng/mL
• • 3. Risk of lymph node involvement\> 15%
• • 4. Patient N0, or Nx
• • 5. Prostate volume estimated on MRI or ultrasound less than 60 cc.
• • 6. Absence of pelvic lymphadenopathy ≥ 15 mm on CT or MRI extension assessment
• • 7. Lack of bone and / or visceral metastasis on CT scan and bone scintigraphy
• • 8. Hormonal treatment started maximum 90 days before the beginning of the irradiation,
• • 9. IPSS score \<12 without alpha blocker treatment
• • 10. Absence of prior pelvic radiotherapy,
• • 11. Lack of surgical treatment for prostate cancer except transurethral resection performed within 6 months before radiotherapy,
• • 12. Age ≥ 18 years and ≤ 85 years,
• • 13. WHO performance index ≤ 1,
• • 14. Estimated life expectancy\> 5 years,
• • 15. Indication of treatment with radiotherapy and validated hormone therapy in a multidisciplinary consultation meeting
• • 16. Affiliation to a social security scheme,
• • 17. Signed informed consent.
• Exclusion Criteria:
• • 1. Prostate cancer of histology other than adenocarcinoma,
• • 2. Patient diagnosed with N1 during imaging or pN1,
• • 3. serum PSA level\> 100 ng / ml,
• • 4. IPSS score ≥ 12 or alpha blocker treatment,
• • 5. Prostate volume estimated on MRI or ultrasound\> 60 cc
• • 6. History of cancer in the 5 years prior to entry into the trial,
• • 7. History of trans-urethral resection of prostate less than 6 months old,
• • 8. History of rectal surgery,
• • 9. History of pelvic irradiation,
• • 10. Patient with severe hypertension not controlled by appropriate treatment,
• • 11. Contraindication to pelvic irradiation,
• • 12. Patient not eligible for brachytherapy
• • Prostate volume\> 60cc
• • Urine flow measurement with max flow \<12 mL / s
• • Or curative anticoagulant treatment
• • Or contraindication to general anesthesia
• • 13. Patient treated with antineoplastic or drug may include methotrexate,
• • 14. Hormone therapy started\> 90 days before the first irradiation,
• • 15. Patient on immunosuppressant therapy
• • 16. Contraindication to agonists or antagonists of LHRH,
• • 17. Bilateral hip prosthesis,
• • 18. Patient already included in another therapeutic trial with an experimental molecule,
• • 19. Patient unable to cooperate during treatment,
• • 20. Persons deprived of their liberty or guardianship,
• • 21. Inability to undergo medical follow-up of the test.