18 and older, male only, with Metastatic Hormone-sensitive Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall SurvivalPrimary· Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Group
Value
95% CI
Androgen-Deprivation Therapy and Docetaxel
57.6
49.1 – 72.8
Androgen-Deprivation Therapy Alone
44.0
34.4 – 49.1
Time to Clinical ProgressionSecondary· Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Group
Value
95% CI
Androgen-Deprivation Therapy and Docetaxel
33.0
27.3 – 41.2
Androgen-Deprivation Therapy Alone
19.8
17.9 – 22.8
Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)Secondary· Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Group
Value
95% CI
Androgen-Deprivation Therapy and Docetaxel
20.2
17.2 – 23.6
Androgen-Deprivation Therapy Alone
11.7
10.8 – 14.7
Proportion of Patients With PSA Complete Response (CR) at 6 MonthsSecondary· Assessed at 6 months
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Group
Value
95% CI
Androgen-Deprivation Therapy and Docetaxel
0.320
0.274 – 0.369
Androgen-Deprivation Therapy Alone
0.196
0.158 – 0.239
Proportion of Patients With PSA Complete Response (CR) at 12 MonthsSecondary· Assessed at 12 months
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
Group
Value
95% CI
Androgen-Deprivation Therapy and Docetaxel
0.277
0.234 – 0.324
Androgen-Deprivation Therapy Alone
0.168
0.132 – 0.209
QOL Change From Baseline to 3 MonthsSecondary· Assessed at baseline and 3 months
The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Group
Value
95% CI
Androgen-Deprivation Therapy and Docetaxel
-2.7
± 0.9
Androgen-Deprivation Therapy Alone
-1.1
± 1.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ECOG-ACRIN Cancer Research Group
Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00309985.