Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)

Official record

Identifier

NCT00967863

Recruiting locations

country

France

Interventions studied

3-dimensional conformal radiation therapyintensity-modulated radiation therapy

Lead sponsor

UNICANCER

Target enrolment

500 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Active, not recruiting

First posted

Aug 28, 2009

Last updated on the registry

Jul 31, 2026

Age

18 Years – 80 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Unfavorable disease, defined by at least 1 of the following criteria:

    * Clinical stage T3 or T4
    * Gleason score ≥8
    * Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL
* pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy
* No pelvic lymph nodes ≥15 mm by CT scan or MRI
* No axillary lymph node involvement (pN1)
* No bone metastasis
* Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy \>5 years
* Must be enrolled in a social security program
* No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
* No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg)
* No contraindication to luteinizing hormone-releasing hormone agonists
* No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
* No hip prosthesis
* Must not be deprived of liberty or under guardianship
* No geographical, social, or psychological reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior pelvic irradiation
* At least 3-4 months since prior transurethral resection
* No other prior surgery for prostate cancer
* No concurrent participation in another clinical trial which would require approval upon entry to this trial