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Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00321698
Recruitment Status : Active, not recruiting
First Posted : May 4, 2006
Results First Posted : December 30, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Garzotto, OHSU Knight Cancer Institute

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Radiation: Intensity-Modulated Radiation Therapy (IMRT)
Drug: Docetaxel+IMRT

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject accrual from Urology clinics started in April 2006; annual follow-up of 22 VA, 3 Oregon Health & Science University (OHSU) (25 total) subjects who completed ended in 2011; 10 year follow-up of these patients will be completed in 2021.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Our 1 screen failure was excluded as a result of having a different type of cancer, other than non-melanoma skin cancer, within the past 5 years.

Reporting Groups
  Description
Phase I, Radiation Only

Group 1=radiation only;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Phase I, Dose 1

Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.

Phase I, Dose 2

Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.

Phase I, Dose 3

Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities.

Phase II, MTD Dose

MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).

Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)


Participant Flow for 2 periods

Period 1:   Phase I, Rad Only & Dose 1-3
    Phase I, Radiation Only   Phase I, Dose 1   Phase I, Dose 2   Phase I, Dose 3   Phase II, MTD Dose
STARTED   3   3   3   3   0 
COMPLETED   3   3   3   3   0 
NOT COMPLETED   0   0   0   0   0 

Period 2:   Phase II, MTD Dose
    Phase I, Radiation Only   Phase I, Dose 1   Phase I, Dose 2   Phase I, Dose 3   Phase II, MTD Dose
STARTED   0   0   0   0   13 [1] 
COMPLETED   0   0   0   0   13 
NOT COMPLETED   0   0   0   0   0 
[1] +1 screen failure



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phase I, Radiation Only

Drug: N/A

4 groups of men in phase I study.

Group 1=radiation only

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Phase I, Dose 1

Drug: docetaxel

4 groups of men in phase I study.

Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Phase I, Dose 2

Drug: docetaxel

4 groups of men in phase I study.

Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Phase I, Dose 3

Drug: docetaxel

4 groups of men in phase I study.

Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Phase II, MTD Dose

Drug: docetaxel

Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation

Radiation: radiation therapy

All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)

Total Total of all reporting groups

Baseline Measures
   Phase I, Radiation Only   Phase I, Dose 1   Phase I, Dose 2   Phase I, Dose 3   Phase II, MTD Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   3   3   13   25 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2  66.7%      2  66.7%      2  66.7%      3 100.0%      11  84.6%      20  80.0% 
>=65 years      1  33.3%      1  33.3%      1  33.3%      0   0.0%      2  15.4%      5  20.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.67  (8.14)   62.67  (7.64)   66.33  (4.93)   58.00  (6.56)   60.54  (4.58)   61.92  (5.89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      3 100.0%      3 100.0%      3 100.0%      3 100.0%      13 100.0%      25 100.0% 
Region of Enrollment 
[Units: Participants]
           
United States   3   3   3   3   13   25 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 5 weeks ]

2.  Primary:   Pathologic Response Rate at the Phase II Dose   [ Time Frame: 4-6 weeks after study treatment ]

3.  Secondary:   Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA   [ Time Frame: Baseline (pre-treatment) and 1 month after surgery (post-treatment) ]

4.  Secondary:   Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)   [ Time Frame: 5 weeks ]

5.  Secondary:   Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures   [ Time Frame: Baseline and 12 Months Post-Prostatectomy ]

6.  Secondary:   Clinical Progression-free Rate as Determined by <0.1ng PSA Results   [ Time Frame: 3, 6, 9, 12 months and annually, up to 5 years ]

7.  Secondary:   Long-term Safety   [ Time Frame: Regular intervals (clinical contact) ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  

8.  Secondary:   Clinical Response to Treatment as Measured by Urologic Examination   [ Time Frame: Regular intervals (clinical contact) ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patient accrual was not completed due to the sponsor withdrawing funding.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Mark Garzotto
Organization: Portland VAMC
phone: 541-728-0665
e-mail: garzotto@ohsu.edu



Responsible Party: Mark Garzotto, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00321698     History of Changes
Other Study ID Numbers: IRB00001581
IIT16179 ( Other Grant/Funding Number: Sanofi-Aventis funding number )
OHSU-1581 ( Other Identifier: OHSU IRB number )
PVAMC-11-1205/ M1675 ( Other Identifier: Portland VA IRB numbers )
OHSU-SOL-05077-L ( Other Identifier: OHSU Knight Cancer Institute number )
CDR0000467219 ( Other Identifier: NCI PDQ ID )
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: December 30, 2014
Results First Posted: December 30, 2016
Last Update Posted: June 26, 2018