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A Phase III Study of Neoadjuvant Docetaxel and Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate (DART)

Phase 3
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

A Phase III Study of Neoadjuvant Docetaxel and Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate (DART)



- To compare disease-free survival rates in patients with high-risk localized
adenocarcinoma of the prostate treated with androgen suppression therapy and
radiotherapy with vs without docetaxel.


- To compare overall survival.

- To compare time to biochemical disease progression.

- To compare time to local disease progression.

- To compare time to distant disease progression.

- To compare time to next anticancer therapy.

- To compare progression-free survival.

- To compare degree of prostate-specific antigen (PSA) suppression prior to radiotherapy.

- To compare quality of life (QOL) using EORTC QLQ C30 and EORTC QLQ PR25 questionnaires
and a trial-specific checklist.

- To compare the nature, severity, and frequency of adverse events.

OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤
7 vs ≥ 8), baseline prostate-specific antigen (PSA) (> 20 ng/mL vs ≤ 20 ng/mL), and
participating center. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive androgen suppression therapy comprising oral flutamide three
times daily or oral bicalutamide once daily for 4 weeks AND leuprolide subcutaneously
(SC) or intramuscularly every 1-6 months, buserelin SC every 2 or 3 months, or
goserelin SC every 1 or 3 months for 3 years. Patients also receive docetaxel IV over
60 minutes on day 1. Treatment with docetaxel repeats every 21 days for up to 4
courses. Beginning at least 4 weeks after completion of chemotherapy, patients undergo
pelvic radiotherapy once daily 5 days a week for up to 8 weeks.

- Arm II: Patients receive androgen suppression therapy and undergo pelvic radiotherapy
as in arm I.

Patients complete quality of life questionnaires at baseline, periodically during treatment,
and then every 6 months for 5 years.

After completion of study treatment, patients are followed at 3 and 6 months, every 6 months
for 5 years, and then annually thereafter.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Localized (N0, M0) disease

- No small cell or transitional cell carcinoma in the biopsy specimen

- Considered to be at high risk for recurrence based on the presence of at least one of
the following adverse prognostic features:

- T stage ≥ 3a

- Gleason score ≥ 8

- Baseline prostate-specific antigen (PSA) > 20 ng/mL

- Deemed to be an appropriate candidate for chemotherapy, as assessed by a medical

- Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and

- Any lymph node appearing ≥ 1.5 cm on CT scan or MRI must be histologically
negative by either needle aspirate or lymph node dissection

- No metastases by chest x-ray and bone scan


- ECOG performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10.0 g/dL

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

- Alkaline phosphatase ≤ 2.5 times ULN

- Total bilirubin normal

- Serum creatinine ≤ 1.5 times ULN

- Able (i.e., sufficiently fluent) and willing to complete the quality of life
questionnaires in either English or French

- Fertile patients must use effective contraception

- No history of other malignancies, except adequately treated nonmelanoma skin cancer
or other curatively treated solid tumor with no evidence of disease for > 5 years

- No serious non-malignant disease resulting in a life expectancy of < 10 years

- No known hypersensitivity to any study medications

- No existing peripheral neuropathy ≥ grade 2

- No bilateral hip replacement prostheses

- No contraindication to pelvic radiotherapy including, but not limited to,
inflammatory bowel disease or severe bladder irritability

- No medical condition that would contraindicate the study treatment regimen, including
severe respiratory insufficiency, uncontrolled diabetes, or severe hypertension

- No other serious illness or psychiatric or medical condition that would preclude
management of the patient according to the study, including active uncontrolled
infection or significant cardiac dysfunction


- Prior androgen suppression therapy allowed provided it was initiated no more than 4
weeks prior to study entry

- At least 4 weeks since prior 5-alpha-reductase inhibitors (e.g., finasteride) for
benign prostatic hypertrophy

- No prior cytotoxic anticancer therapy

- No prior chemotherapy for carcinoma of the prostate

- No prior surgical treatment for carcinoma of the prostate, except transurethral
resection or bilateral orchiectomy

- No prior pelvic radiotherapy

- No concurrent nilutamide

- No other concurrent investigational drugs

- No other concurrent anticancer therapy (cytotoxic therapy, biologic/immunotherapy, or

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:


Principal Investigator

Michael R. McKenzie, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency


Canada: Health Canada

Study ID:




Start Date:

March 2008

Completion Date:

January 2011

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms