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

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ClinicalTrials.gov Identifier: NCT00423475
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
UNICANCER

Study Description
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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 from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: goserelin acetate Procedure: adjuvant therapy Radiation: radiation therapy Phase 3

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 undergone surgery for recurrent or refractory prostate cancer.

Secondary

  • Compare overall survival of patients treated with these regimens.
  • Compare metastases-free survival of patients treated with these regimens.
  • Compare the immediate and delayed toxicities of these regimens.
  • Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.
  • Compare the quality of life at 1 and 5 years after radiotherapy in these patients.
  • Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.

OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
  • Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later.

Quality of life is assessed periodically.

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

PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 743 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
Actual Study Start Date : October 2006
Actual Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: I
Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
 Procedure: adjuvant therapy
Radiation: radiation therapy
Experimental: II
Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
 Drug: goserelin acetate
Other Name: ZOLADEX

Procedure: adjuvant therapy
Radiation: radiation therapy


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free (biological and/or clinical) survival [ Time Frame: 3.5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: not yet evaluable ]
  2. Metastases-free survival [ Time Frame: not yet evaluable ]
  3. Immediate and delayed toxicities [ Time Frame: not yet evaluable ]
  4. Delay in reaching the prostate-specific antigen nadir [ Time Frame: not yet evaluable ]
  5. Quality of life at 1 and 5 years after radiotherapy [ Time Frame: not yet evaluable ]
  6. Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Time Frame: not yet evaluable ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423475


Locations
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Sponsors and Collaborators
UNICANCER
AstraZeneca
Investigators
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Study Chair: Christian Carrie, MD Centre Leon Berard
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00423475    
Other Study ID Numbers: GETUG-AFU 16 - UC-0160/0504
EUDRACT-2005-005165-11
CDR0000523446
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by UNICANCER:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
 stage III prostate cancer
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents