Clinical trial · Interventional
Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)
Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy
NCT00967863CI-TRIAL-00120088active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
- interventionNames
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: intensity-modulated radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
- interventionNames
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: intensity-modulated radiation therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 trialReferences
Publications (2)
- DERIVEDHennequin C, Sargos P, Roca L, Silva M, Latorzeff I, Peiffert D, Cozzi S, Benyoucef A, Hasbini A, Supiot S, Ronchin P, Wachter T, Azria D, Magne N, Zibouche M, Vial N, Cormier L. High-dose radiotherapy in patients with high-risk prostate cancers treated with long-term androgen deprivation therapy (GETUG AFU 18): a randomised, phase 3 trial. Lancet Oncol. 2026 Sep;27(9):1158-1167. doi: 10.1016/S1470-2045(26)00277-9. PMID 42636837
- DERIVEDKim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2. PMID 36884035