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Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT (86.4 GY) Alone With IMRT to 75.6 GY Plus Neoadjuvant/Adjuvant Androgen Deprivation in Patients With High Grade Intermediate Risk and Unfavorable Risk Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT (86.4 GY) Alone With IMRT to 75.6 GY Plus Neoadjuvant/Adjuvant Androgen Deprivation in Patients With High Grade Intermediate Risk and Unfavorable Risk Prostate Cancer


OBJECTIVES:

- Compare the quality of life of patients with high-grade intermediate-risk or
unfavorable-risk adenocarcinoma of the prostate when treated with high-dose
intensity-modulated radiotherapy alone versus with androgen deprivation comprising
bicalutamide and goserelin.

- Compare the prostate-specific antigen relapse-free, distant metastases-free, and
overall survival of patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the local control in patients treated with these regimens, based on
post-treatment sextant biopsies performed 4 years after study completion.

OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific
antigen level, Gleason score, and clinical stage. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo high-dose intensity-modulated radiotherapy (IMRT) 4-5 times per
week for 10 weeks (a total of 48 treatments).

- Arm II: Patients receive oral bicalutamide once daily for 18.5 weeks. Three to seven
days after the initiation of bicalutamide, patients also receive goserelin
subcutaneously monthly for 2 years. Beginning after 10 weeks of hormonal therapy,
patients undergo concurrent high-dose IMRT 4-5 times per week for 8.5 weeks (a total of
42 treatments). Patients discontinue bicalutamide on or near the end of radiotherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

Quality of life is assessed at baseline, every 3 months for 1.5 years after the completion
of radiotherapy, then 6 months later, and then annually for 2 years.

Patients are followed every 6-8 months for 4 years and then annually for 2 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
study within 4-5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Unfavorable-risk disease, including at least 2 of the following characteristics:

- Prostate-specific antigen level greater than 10 ng/mL

- Gleason score greater than 7

- Stage T4

- Intermediate-risk disease with a Gleason score of at least 8 allowed

- Lymph nodes clinically negative by imaging studies or histologically negative by node
sampling or lymph node dissection

- Prostate size less than 75 grams

- No distant metastases by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 80-100%

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT and SGPT no greater than 1.5 times ULN

Renal

- Not specified

Other

- No documented history of inflammatory bowel disease

- No bilateral hip replacements

- No other invasive cancer except localized basal cell or squamous cell skin cancer
unless disease free for at least 5 years

- No major medical or psychiatric illness that would preclude study completion,
compliance, or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for prostate cancer

Endocrine therapy

- No prior androgen-deprivation therapy

Radiotherapy

- No prior pelvic radiotherapy

- No prior prostate brachytherapy

Surgery

- No prior bilateral orchiectomy

- No prior radical prostatectomy

- No prior cryotherapy for prostate cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

compare the quality of life

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michael J. Zelefsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-040

NCT ID:

NCT00067015

Start Date:

May 2003

Completion Date:

September 2008

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021