Evaluating a new radiotherapy approach for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and tolerance of a hypofractionated radiotherapy regimen followed by a boost for patients with adverse intermediate or high-risk prostate adenocarcinoma. The approach involves delivering a higher biological dose in fewer sessions compared to conventional treatments, aiming to minimize toxicity while maintaining effectiveness. The study will assess the rates of digestive and urinary toxicity associated with this treatment method, building on previous encouraging results that suggest acceptable levels of side effects. Participants will receive prostatic boost brachytherapy with high dose rate (HDR) as part of their treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Georges François Leclerc
  Dijon, France Recruiting
• Cgfl
  Dijon, France Recruiting

Study contacts

• Study coordinator: Magalie QUIVRIN
• Email: mquivrin@cgfl.fr
• Phone: 03.80.73.75.00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting who responds to anti-PD-1/PD-L1 therapy using blood extracellular vesicle tests

  This study tests whether immune biomarkers found in blood extracellular vesicles can predict who with NSCLC or unresectable melanoma will respond to anti-PD-1/PD-L1 therapies.

  Recruiting at 2 sites Centre Georges Francois Leclerc · Besançon and 4 other locations · NCT07376512

• Understanding Cancer Patients' Preferences for Genetic Information Before Exome Analysis

  This study is trying to find out how cancer patients want to receive genetic information before they have a specific genetic test, to make sure they understand their treatment options better.

  Recruiting at 2 sites Centre Georges Francois Leclerc · Dijon and 1 other locations · NCT06550687

• Ultra-rapid testing for BRCA1/2 mutations in breast cancer patients

  This study tests a fast BRCA1/2 mutation screening for breast cancer patients to see if it can reduce their waiting time for results and help ease their anxiety.

  Recruiting at 2 sites Centre Georges Francois Leclerc · Dijon and 1 other locations · NCT06111417

• Evaluating FOLFIRINOX treatment for advanced pancreatic cancer

  This study is testing if a specific chemotherapy called FOLFIRINOX can help people with advanced pancreatic cancer feel better and live longer compared to other treatments.

  Recruiting Phase 2 Centre Georges Francois Leclerc · Dijon · NCT05988814

• Evaluating a new treatment for advanced lung cancer with low PD-L1 levels

  This study is testing a new treatment combining mirdametinib and chemotherapy for people with advanced lung cancer and low PD-L1 levels to see if it helps them.

  Recruiting Phase 1/2 Centre Georges Francois Leclerc · Dijon, Burgundy · NCT05937906

• Using a non-magnetic screen to guide breathing during MRI-guided radiotherapy for mobile cancerous lesions

  This study is testing if using a special non-magnetic screen during MRI-guided radiotherapy can help patients with mobile cancerous lesions breathe better and improve their treatment experience.

  Recruiting Centre Georges Francois Leclerc · Dijon, Côte d'Or · NCT05783908

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.