Adults 18 to 100, male only, with 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.
Maximum Tolerated Dose (MTD)Primary· 5 weeks
Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel.
The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling).
MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experie
Group
Value
95% CI
Phase I Dose 1-4
30
Pathologic Response Rate at the Phase II DosePrimary· 4-6 weeks after study treatment
Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:
The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
Pathologic Stage pT2c
Group
Value
95% CI
Phase II MTD Dose
7
Pathologic Stage pT3a
Group
Value
95% CI
Phase II MTD Dose
3
Pathologic Stage pT3b
Group
Value
95% CI
Phase II MTD Dose
3
Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSASecondary· Baseline (pre-treatment) and 1 month after surgery (post-treatment)
All participants were combined for this assessment as pre-specified in the protocol.
The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported.
PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years
Group
Value
95% CI
All Research Participants
-49.1
-60.3 – -36.7
Long-term SafetySecondary· Regular intervals both study-related and clinical standard of care-related; assessed at end of study treatment. Average timeframe to follow safety was 1 year and includes all grade 3-4 adverse events
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Group
Value
95% CI
Phase I Dose 1-4
9
Phase II MTD Dose
8
Clinical Response to Treatment as Measured by Urologic ExaminationSecondary· Each participant was examined 3, 6, 9, 12 months, and annually for an average of 10 years after surgery.
Biochemical Recurrence is defined as a detectable or rising PSA value after surgery that is 0.2 ng/mL or greater with a second confirmatory level of 0.2 ng/mL or greater.
Group
Value
95% CI
Phase I, Radiation Only
1
Phase I, Dose 1
2
Phase I, Dose 2
0
Phase I, Dose 3
2
Phase II, MTD Dose
5
Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)Secondary· 5 weeks
Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:
The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body.
Group
Value
95% CI
Phase I Dose 1-4
9
Phase II MTD Dose
13
Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's MeasuresSecondary· Baseline and 12 Months Post-Prostatectomy
Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score.
AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe.
EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate ca
AUA Symptom Score
Group
Value
95% CI
All Research Participants
0.67
-2.96 – 4.29
EPIC Urinary Incontinence Score
Group
Value
95% CI
All Research Participants
-36.52
-51.38 – -21.67
EPIC Urinary Obstructive/Irritative Score
Group
Value
95% CI
All Research Participants
3.41
-5.55 – 12.37
EPIC Bowel
Group
Value
95% CI
All Research Participants
1.45
-6.42 – 9.33
EPIC Hormonal
Group
Value
95% CI
All Research Participants
0.00
-6.42 – 6.42
EPIC Sexual
Group
Value
95% CI
All Research Participants
-36.26
-48.84 – -23.68
Clinical Progression-free Rate as Determined by <0.1ng PSA ResultsSecondary· 3, 6, 9, 12 months and annually, up to 5 years
The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.
Group
Value
95% CI
All Research Participants
62.8
41.9 – 83.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for high-risk localized prostate cancer.
Publications & conference data
1 peer-reviewed publication 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 OHSU Knight Cancer Institute
Last refreshed: 29 August 2024
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/NCT00321698.