Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer (PR05)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01040624
Recruitment Status : Active, not recruiting
First Posted : December 29, 2009
Results First Posted : July 22, 2015
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Radiation: < 15% risk of + LN
Radiation: > 15% risk of + LN
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HR-A HR-B
Hide Arm/Group Description

< 15% risk of + lymph nodes (LN)

< 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.

> 15% risk of + LN

> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

Period Title: Overall Study
Started 58 19
Completed 58 19
Not Completed 0 0
Arm/Group Title HR-A HR-B Total
Hide Arm/Group Description

< 15% risk of + LN

< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

> 15% risk of + LN

> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

Total of all reporting groups
Overall Number of Baseline Participants 58 19 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 19 participants 77 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  27.6%
4
  21.1%
20
  26.0%
>=65 years
42
  72.4%
15
  78.9%
57
  74.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 58 participants 19 participants 77 participants
68
(52 to 80)
69
(51 to 79)
68
(51 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 19 participants 77 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
58
 100.0%
19
 100.0%
77
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 19 participants 77 participants
58 19 77
1.Primary Outcome
Title Acute Grade 3 or Higher Treatment-related Toxicity Rate.
Hide Description Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
Time Frame 6 months after the completion of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HR-A HR-B
Hide Arm/Group Description:

< 15% risk of + LN

< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

> 15% risk of + LN

> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

Overall Number of Participants Analyzed 58 19
Measure Type: Number
Unit of Measure: participants
1 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HR-A, HR-B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments One-sided binomial test of univariate probability distributions
2.Secondary Outcome
Title Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
Hide Description [Not Specified]
Time Frame After radiation: every 6 months for 3 years, then annually for 20 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
Hide Description [Not Specified]
Time Frame After radiation: every 6 months for 3 years, then annually for 20 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HR-A HR-B
Hide Arm/Group Description

< 15% risk of + LN

< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

> 15% risk of + LN

> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

All-Cause Mortality
HR-A HR-B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
HR-A HR-B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/58 (1.72%)      3/19 (15.79%)    
Gastrointestinal disorders     
Diarrhea - acute  1  0/58 (0.00%)  0 3/19 (15.79%)  3
Constipation - acute  1  1/58 (1.72%)  1 0/19 (0.00%)  0
Abdominal cramping - acute  1  0/58 (0.00%)  0 1/19 (5.26%)  1
General disorders     
Pain - acute  1  0/58 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HR-A HR-B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/58 (22.41%)      11/19 (57.89%)    
Gastrointestinal disorders     
Constipation - acute  1  5/58 (8.62%)  5 2/19 (10.53%)  2
Diarrhea - acute  1  4/58 (6.90%)  4 7/19 (36.84%)  7
Abdominal cramping acute  1  1/58 (1.72%)  1 2/19 (10.53%)  2
Proctitis - acute  1  1/58 (1.72%)  1 1/19 (5.26%)  1
Rectal bleeding - late  1  2/58 (3.45%)  2 1/19 (5.26%)  1
Abdominal cramping - late  1  1/58 (1.72%)  1 0/19 (0.00%)  0
Constipation - late  1  1/58 (1.72%)  1 0/19 (0.00%)  0
General disorders     
Pain - acute  1  6/58 (10.34%)  6 2/19 (10.53%)  2
Renal and urinary disorders     
Dysuria - acute  1  3/58 (5.17%)  3 0/19 (0.00%)  0
Obstruction - acute  1  1/58 (1.72%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Layout table for Results Point of Contact information
Name/Title: Nancy P. Mendenhall, MD
Organization: University of Florida Health Proton Therapy Institute
Phone: 904-588-1000
EMail: rtoton@floridaproton.org
Publications:
American Joint Committee on Cancer. AJCC Cancer Staging Handbook, 6th ed. New York: Springer Verlag; 2002.
Mendenhall NP, Li X, Morris CG, Keole S, Mendenhall WM, Nichols RC, Vargas C, Henderson RH, Early GI and GU toxicity in 3 prospective proton therapy trials for prostate cancer. Presented at the American Society of Therapeutic Radiation Oncologists. Chicago, 2009.
American Cancer Society Cancer facts and figures. 1994;
Cox JD, Kian AK. Mosby Radiation Oncology: Rationale, Technique, Results, 8th ed.C.V. Mosby; 2002.
Vargas C, Martinez A, Boike TP, Edmundson G, Gustafson G, Krauss D. Long Term Survival Benefit of a Prospective Dose Escalation Trial Using High Dose Rate (HDR) Brachytherapy Boost. [Abstr.] Int J Radiat Oncol Biol Phys 2005;63:S37-S38.
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01040624    
Other Study ID Numbers: UFPTI 0703 - PR05
First Submitted: December 24, 2009
First Posted: December 29, 2009
Results First Submitted: June 25, 2015
Results First Posted: July 22, 2015
Last Update Posted: June 5, 2019