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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00967863
• Other study ID #: CDR0000649028 UC-0160/0706
• Secondary ID: FRE-FNCLCC-GETUG
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2008
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

Primary

• Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer receiving prolonged hormone therapy.

Secondary

• Evaluate overall and specific survival.

• Assess acute and late toxicities of different modalities (conformal or intensity-modulated radiotherapy).

• Evaluate toxicities of the different doses with respect to hormonal therapy.

• Assess the quality of life (QLQ-C30 and PR 25).

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.

• Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.

In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3 years.

After completion of study treatment, patients are followed up periodically for 10 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: October 2026
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 3-dimensional conformal radiation therapy
Patients undergo radiotherapy
• intensity-modulated radiation therapy
Patients undergo radiotherapy

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest Paul Papin	Angers
France	Institut Bergonie	Bordeaux
France	Centre Francois Baclesse	Caen
France	Centre hospitalier Métropole Savoie	Chambéry
France	Clinique Léonard de Vinci	Chambray-lès-Tours
France	CHU Henri Mondor	Créteil
France	Centre Léon Bérard	Lyon
France	Hopital La Timone	Marseille
France	Centre de Cancérologie du Grand Montpellier	Montpellier
France	Centre Val D'Aurelle	Montpellier
France	Centre Azureen de Cancerologie	Mougins
France	Chr Orleans	Orléans
France	Hôpital Saint Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Centre CARIO - HPCA	Plérin
France	Hôpital Jean Bernard - CHU de Poitiers	Poitiers
France	Centre Eugène Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre Rene Gauducheau	Saint-Herblain
France	Hia Begin	Saint-Mandé
France	Institut de Cancérologie LUCIEN NEUWIRTH	Saint-Priest-en-Jarez
France	Centre Paul Strauss	Strasbourg
France	Clinique PASTEUR	Toulouse
France	Ch Bretonneau	Tours
France	Centre Alexis Vautrin	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical or clinical progression-free survival at 5 years		5 years
Secondary	Overall and specific survival		10 years
Secondary	Acute and late toxicity		10 years
Secondary	Quality of life as measured by QLQ-C30 and PR 25 questionnaires		10 years

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database