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A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer



- Compare the relative efficacy, in terms of overall survival, of the combination of
androgen suppression and radiotherapy versus androgen suppression and radiotherapy
followed by docetaxel and prednisone in patients with localized, high-risk prostate


- Compare the disease-free survival and incidence of adverse events in patients treated
with these regimens.

- Compare the biochemical control, local control, and freedom from distant metastases in
patients treated with these regimens.

- Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a
surrogate for overall survival of patients treated with these regimens.

- Compare the time interval between biochemical failure and distant metastases with
respect to testosterone level in patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to risk group.

- Arm I: Patients receive androgen suppression therapy comprising luteinizing
hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin,
buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily
for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8,
patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen
therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy
continues for 20 months.

- Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in
arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel
IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every
21 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients continue LHRH agonist therapy as in arm I.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed prostate cancer at high-risk for recurrence within the past
180 days as determined by 1 of the following combinations (risk groups):

- Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage

- Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2

- Gleason score 8, PSA 20-150 ng/mL, and any T stage

- Gleason score 7, PSA 20-150 ng/mL, and any T stage

- Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal
sampling, or dissection within 90 days prior to study entry

- Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed

- Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a
corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed

- PSA ≤ 150 ng/mL

- Cannot have been obtained during any of the following time points:

- 10-day period after prostate biopsy

- After initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

- No distant metastases by physical exam and bone scan

- Equivocal bone scan findings allowed if plain films are negative


- Zubrod performance status 0-1

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,800/mm^3

- Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)

- ALT and AST ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Fertile patients must use effective contraception during and for at least 3 months
after completion of study treatment

- No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy,
unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or
bladder are allowed)

- No unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- No transmural myocardial infarction within the past 6 months

- No acute bacterial or fungal infection requiring intravenous antibiotics


- No prior allergic reaction to any study drugs or other drugs formulated with
polysorbate 80

- No existing peripheral neuropathy ≥ grade 2


- At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for
prostatic hypertrophy

- At least 90 days since prior testosterone

- Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen
ablation was initiated no more than 50 days prior to study entry

- No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral

- No prior systemic chemotherapy for prostate cancer

- Prior chemotherapy for a different cancer is allowed

- No prior radiotherapy, including brachytherapy, to the region of prostate cancer that
would result in overlap of radiotherapy fields

- Intensity modulated radiotherapy allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 4 years after registration

Safety Issue:


Principal Investigator

Howard M. Sandler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage III prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



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