Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-14

Study Completion Date

2017-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

NCT00030654

Prostate Cancer

COMPLETED PHASE3

Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

NCT00023829

Prostate Cancer

COMPLETED PHASE3

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

NCT00004054

Prostate Cancer

COMPLETED PHASE3

Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

NCT00002597

Prostate Cancer

COMPLETED PHASE3

Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

NCT00003653

Prostate Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

* Determine the effect of one year of adjuvant hormonal ablation on disease-free survival at 5 years in node-negative radical prostatectomy patients at high risk for progression.
* Determine the effect of this treatment on the incidence of androgen independent prostate cancer and on disease specific and overall survival.
* Determine the impact of one year of total androgen ablation on quality of life and serum testosterone levels.
* Assess differences in quality of life between wives of patients in the androgen ablation condition compared to wives of patients in the control condition.
* Obtain blood samples from patients at high risk for failure post-prostatectomy to evaluate serum markers of prognosis.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.
* Arm II: Patients receive no initial treatment. Quality of life is assessed every 6 months for 5 years. Quality of life of wives/partners of patients is assessed every 6 months for two years.

Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I - Leuprolide + Flutamide

Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.

Group Type EXPERIMENTAL

Flutamide

Intervention Type DRUG

10.8 mg intramuscularly once every 3 months for 12 months

Leuprolide Acetate

Intervention Type DRUG

50 mg tablet orally daily for 12 months

Arm II - No Treatment

Arm II: Patients receive no initial treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flutamide

10.8 mg intramuscularly once every 3 months for 12 months

Intervention Type DRUG

Leuprolide Acetate

50 mg tablet orally daily for 12 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Goserelin Zoladex Casodex Bicalutamide

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging
2. Radical prostatectomy and bilateral lymph node dissection performed
3. Pathologic assessment of surgical specimens by MDACC pathologist
4. High risk of clinical or biochemical failure post prostatectomy (must fulfill one of the following criteria): pathology; a) Gleason grade sum score greater than or equal to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive surgical margins and Gleason greater than or equal to 7
5. Radical prostatectomy performed within 90 days of enrollment and serum PSA level \< 0.1ng/ml
6. Written informed consent

Exclusion Criteria

1. Any evidence of metastatic disease confirmed prior to enrollment
2. Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5).
3. Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer
4. Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study
5. Elevation of liver function tests 2x normal
6. Contraindication to the use of LH-RH agonists or antiandrogens
7. Active secondary malignancy (other than squamous or basal cell skin cancer) within five years prior to enrollment in study
8. Any concomitant medical condition that would make it undesirable for the 7patient to participate in the trial or jeopardize compliance with the protocol

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Curtis A. Pettaway, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Michael O. Koch, MD

Role: STUDY_CHAIR

Indiana University Melvin and Bren Simon Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document