Trial Outcomes & Findings for Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy (NCT NCT00480857)

NCT ID: NCT00480857

Last Updated: 2017-10-06

Results Overview

The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: 4 years
• Results posted on: 2017-10-06

Participant Flow

Participant milestones

Measure	Docetaxel Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Overall Study STARTED	19
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Docetaxel Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Overall Study Lack of Efficacy	2

Baseline Characteristics

Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

Baseline characteristics by cohort

Measure	Docetaxel n=19 Participants Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Age, Continuous	66 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	19 Participants n=93 Participants

PRIMARY outcome

Timeframe: 4 years

The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.

Outcome measures

Measure	Docetaxel n=19 Participants Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Percentage of Patients Alive Without Progression at 4 Years	42 percentage of patients Interval 24.0 to 60.0

SECONDARY outcome

Timeframe: 4 years

To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

Outcome measures

Measure	Docetaxel n=19 Participants Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less	12 patients

SECONDARY outcome

Timeframe: 4 years

To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.

G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening

Outcome measures

Measure	Docetaxel n=19 Participants Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities Patients that experience at least 1 G2 toxicity	50 percentage of patients
The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities Patients that experience at least 1 G3 toxicity	58 percentage of patients
The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities Patients that experience at least 1 G4 toxicity	11 percentage of patients
The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities Patients that experience at least 1 G1 toxicity	79 percentage of patients

SECONDARY outcome

Timeframe: 4 years

The number of patients that have local disease recurrence by imaging and clinical findings.

Outcome measures

Measure	Docetaxel n=19 Participants Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
The Number of Patients That Experience Evidence of Local Recurrence	0 Participants

SECONDARY outcome

Timeframe: 4 years

The number of patients alive at 4 years.

Outcome measures

Measure	Docetaxel n=19 Participants Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
The Number of Patients Alive	18 Participants

Adverse Events

Docetaxel

Serious events: 6 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Docetaxel n=19 participants at risk Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
Blood and lymphatic system disorders Lymphopenia	21.1% 4/19
Gastrointestinal disorders Upper Gastrointestinal Bleed	5.3% 1/19
Gastrointestinal disorders Hematochezia	5.3% 1/19

Other adverse events

Measure	Docetaxel n=19 participants at risk Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
General disorders Fatigue	73.7% 14/19
Gastrointestinal disorders Bowel Frequency/Urgency	42.1% 8/19
Renal and urinary disorders Urinary Frequency/Urgency	31.6% 6/19
General disorders Other	15.8% 3/19
Gastrointestinal disorders Hematochezia	15.8% 3/19
Nervous system disorders Neuropathy	21.1% 4/19
Blood and lymphatic system disorders Thrombocytopenia	15.8% 3/19
Blood and lymphatic system disorders Anemia	15.8% 3/19
Blood and lymphatic system disorders Neutropenia	73.7% 14/19
Gastrointestinal disorders Rectal	21.1% 4/19
General disorders Weights Loss	5.3% 1/19
Gastrointestinal disorders Upper GI Bleed	5.3% 1/19

Additional Information

Dr. Daniel Hamstra

University of Michigan Comprehensive Cancer Center

Phone: (734) 936-4300

Email: dhamm@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place