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Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer

Primary Purpose

Neoplasm, Prostate

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Immediate Orchiectomy or depot LHRH
Delayed Orchiectomy or depot LHRH
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm, Prostate focused on measuring Malignant Neoplasm of Prostate, Tumor-node-metastasis (TNM) Staging Regional Lymph Nodes (N0-2), Not suitable for local treatment with curative intent

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy).
  • All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation.
  • Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation.
  • Life expectancy of at least six months.
  • WHO performance status score 0-1.
  • Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue.
  • Continuous follow-up until death if possible.

Exclusion Criteria:

  • Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin.
  • Prostate cancer known for longer than one month before entering the study.
  • Pain caused by the prostate cancer or its metastases.
  • Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion.
  • Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins).
  • Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4).
  • Patients with evidence of distant metastases (bone, lung, liver).
  • Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason).
  • Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals.

Expected difficulties with follow-up for any reason.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Immediate Endocrine Therapy

    Delayed Endocrine Therapy

    Arm Description

    Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization.

    Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.

    Outcomes

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Overall symptom free survival time
    Time until first evidence of distant progression
    Prognostic importance of pretreatment laboratory data
    prostate cancer mortality and overall mortality according to pretreatment laboratory data
    Prognosis of particular sub-groups
    prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.

    Full Information

    First Posted
    March 18, 2013
    Last Updated
    March 22, 2013
    Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01819285
    Brief Title
    Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer
    Official Title
    Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1990 (undefined)
    Primary Completion Date
    July 2004 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    European Organisation for Research and Treatment of Cancer - EORTC

    4. Oversight

    5. Study Description

    Brief Summary
    Objectives I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy). II. Compare the overall survival of these two groups of patients. III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups. IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy. V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasm, Prostate
    Keywords
    Malignant Neoplasm of Prostate, Tumor-node-metastasis (TNM) Staging Regional Lymph Nodes (N0-2), Not suitable for local treatment with curative intent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    985 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate Endocrine Therapy
    Arm Type
    Active Comparator
    Arm Description
    Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization.
    Arm Title
    Delayed Endocrine Therapy
    Arm Type
    Experimental
    Arm Description
    Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.
    Intervention Type
    Procedure
    Intervention Name(s)
    Immediate Orchiectomy or depot LHRH
    Intervention Type
    Procedure
    Intervention Name(s)
    Delayed Orchiectomy or depot LHRH
    Primary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    13 years from first patient in
    Secondary Outcome Measure Information:
    Title
    Overall symptom free survival time
    Time Frame
    13 years from first patient in
    Title
    Time until first evidence of distant progression
    Time Frame
    13 years from first patient in
    Title
    Prognostic importance of pretreatment laboratory data
    Description
    prostate cancer mortality and overall mortality according to pretreatment laboratory data
    Time Frame
    13 years from first patient in
    Title
    Prognosis of particular sub-groups
    Description
    prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.
    Time Frame
    13 years from first patient in

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy). All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation. Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation. Life expectancy of at least six months. WHO performance status score 0-1. Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue. Continuous follow-up until death if possible. Exclusion Criteria: Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin. Prostate cancer known for longer than one month before entering the study. Pain caused by the prostate cancer or its metastases. Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion. Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins). Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4). Patients with evidence of distant metastases (bone, lung, liver). Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason). Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals. Expected difficulties with follow-up for any reason.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Urs Studer, MD
    Organizational Affiliation
    Insel Gruppe AG, University Hospital Bern
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23932338
    Citation
    Studer UE, Whelan P, Wimpissinger F, Casselman J, de Reijke TM, Knonagel H, Loidl W, Isorna S, Sundaram SK, Collette L; EORTC Genitourinary Cancer Group. Differences in time to disease progression do not predict for cancer-specific survival in patients receiving immediate or deferred androgen-deprivation therapy for prostate cancer: final results of EORTC randomized trial 30891 with 12 years of follow-up. Eur Urol. 2014 Nov;66(5):829-38. doi: 10.1016/j.eururo.2013.07.024. Epub 2013 Jul 24.
    Results Reference
    derived
    Links:
    URL
    http://www.eortc.be/clinicaltrials/details.asp?protocol=30891
    Description
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    Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer

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