Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Biochemical or clinical progression-free survival at 5 years [ Designated as safety issue: No ]
- Overall and specific survival [ Designated as safety issue: No ]
- Acute and late toxicity [ Designated as safety issue: Yes ]
- Quality of life as measured by QLQ-C30 and PR 25 questionnaires [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
|
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy
|
|
Experimental: Arm II
Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
|
Radiation: 3-dimensional conformal radiation therapy
Patients undergo radiotherapy
Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 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:
- 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
Contacts and Locations| France | |
| Federation Nationale des Centres de Lutte Contre le Cancer | Recruiting |
| Paris, France, 75475 | |
| Contact: Christophe Hennequin, PhD 33-1-4249-4949 christophe.hennequin@sls.ap-hop-paris.fr | |
| Principal Investigator: | Christophe Hennequin, PhD | Hopital Saint-Louis |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00967863 History of Changes |
| Other Study ID Numbers: | CDR0000649028, FRE-FNCLCC-GETUG-18/0706, 2008-A00529-46, EU-20966 |
| Study First Received: | August 27, 2009 |
| Last Updated: | September 29, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013