Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
MALE
NCT03417336

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

Led by Centre Georges Francois Leclerc · Updated on 2025-02-17

90

Participants Needed

2

Research Sites

586 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of prostate adenocarcinoma
  • Gleason score 7-10 with T1c-T2b and PSA less than 50 ng/mL, or
  • Gleason score 6 with T2c-T4 or biopsy involvement ≥ 50% and PSA less than 50 ng/mL, or
  • Gleason score 6 with T1c-T2b and PSA greater than 20 ng/mL
  • Risk of lymph node involvement greater than 15%
  • No lymph node involvement (N0 or Nx)
  • Prostate volume less than 60 cc on MRI or ultrasound
  • No pelvic lymphadenopathy ≥ 15 mm on CT or MRI
  • No bone or visceral metastases on CT scan and bone scan
  • Hormonal treatment started no more than 90 days before radiotherapy
  • IPSS score less than 12 without alpha blocker treatment
  • No prior pelvic radiotherapy
  • No prostate surgery except transurethral resection within 6 months before radiotherapy
  • Age between 18 and 85 years
  • WHO performance status 0 or 1
  • Estimated life expectancy greater than 5 years
  • Indication for radiotherapy and hormone therapy validated by multidisciplinary consultation
  • Affiliated with a social security scheme
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Prostate cancer histology other than adenocarcinoma
  • N1 nodal involvement diagnosed by imaging or pN1
  • Serum PSA level greater than 100 ng/mL
  • IPSS score 12 or higher or alpha blocker treatment
  • Prostate volume greater than 60 cc on MRI or ultrasound
  • History of cancer within 5 years prior to trial entry
  • Transurethral resection of prostate less than 6 months old
  • History of rectal surgery
  • History of pelvic irradiation
  • Severe uncontrolled hypertension
  • Contraindications to pelvic irradiation
  • Not eligible for brachytherapy due to prostate volume, low urine flow, anticoagulant treatment, or anesthesia contraindication
  • Treatment with antineoplastic drugs including methotrexate
  • Hormone therapy started more than 90 days before radiotherapy
  • Use of immunosuppressant therapy
  • Contraindications to LHRH agonists or antagonists
  • Bilateral hip prosthesis
  • Participation in another trial with experimental treatment
  • Inability to cooperate during treatment
  • Persons deprived of liberty or guardianship
  • Unable to undergo medical follow-up of the study

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Centre Georges François Leclerc

Dijon, France, 21000

Actively Recruiting

2

CGFL

Dijon, France, 21079

Actively Recruiting

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Research Team

M

Magalie QUIVRIN

CONTACT

E

Emilie REDERSTORFF

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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