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Status:

COMPLETED

Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

Lead Sponsor:

UNICANCER

Collaborating Sponsors:

AstraZeneca

Conditions:

Prostate Cancer

Eligibility:

MALE

18-120 years

Phase:

PHASE3

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands f...

Detailed Description

OBJECTIVES: Primary * Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have under...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the prostate
  • Localized disease treated with surgery only
  • pT2, pT3, or pT4
  • pN0 or pNx
  • No clinical signs of progressive disease
  • Prostate-specific antigen (PSA) meeting the following criteria:
  • PSA ≤ 0.1 ng/mL after prostatectomy
  • PSA ≥ 0.2 ng/mL and \< 2 ng/mL at study entry
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Life expectancy ≥ 10 years
  • No other cancer in the past 5 years except for treated basal cell skin cancer
  • No known pituitary gland adenoma
  • No uncontrolled hypertension (i.e., blood pressure ≥ 160 mm Hg systolic and/or 90 mm Hg diastolic)
  • No geographical, social, or psychological condition that would preclude study treatment
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior hormonal therapy
  • No prior pelvic radiotherapy
  • No prior surgical or chemical castration
  • At least 6 months since surgery for biological recurrence
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    October 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    743 Patients enrolled

    Trial Details

    Trial ID

    NCT00423475

    Start Date

    October 1 2006

    Last Update

    May 17 2018

    Active Locations (31)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (31 locations)

    1

    Centre Paul Papin

    Angers, France, 49036

    2

    Institut Sainte Catherine

    Avignon, France, 84082

    3

    Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, France, 25030

    4

    Institut Bergonie

    Bordeaux, France, 33076