Evaluating a new radiotherapy approach for high-risk prostate cancer

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

This study is testing a new way of giving radiation therapy to see if it can effectively treat high-risk prostate cancer with fewer sessions and less side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Centre Georges Francois Leclerc (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 2 sites (Dijon and 1 other locations)
• Trial ID: NCT03417336 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 to 85 with specific types of prostate adenocarcinoma and no prior pelvic radiotherapy.

Not a fit: Patients with advanced metastatic disease or those who have undergone prior pelvic radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less toxic option for patients with high-risk prostate cancer.

How similar studies have performed: Previous studies have shown promising results with similar hypofractionated approaches, indicating potential for success in this novel application.

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.

Where this trial is running

Dijon and 1 other locations

• Centre Georges François Leclerc — Dijon, France (Recruiting)
• Cgfl — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Magalie QUIVRIN

Conditions To Evaluate the Rate of Digestive and Urinary Toxicity