Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00967863
First received: August 27, 2009
Last updated: September 29, 2009
Last verified: August 2009
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Biochemical or clinical progression-free survival at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967863

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   
Sponsors and Collaborators
UNICANCER
Investigators
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014