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

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ClinicalTrials.gov Identifier: NCT01040624
Recruitment Status : Active, not recruiting
First Posted : December 29, 2009
Results First Posted : July 22, 2015
Last Update Posted : June 29, 2018
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HR-A

< 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.

HR-B

> 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.


Participant Flow:   Overall Study
    HR-A   HR-B
STARTED   58   19 
COMPLETED   58   19 
NOT COMPLETED   0   0 



  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
HR-A

< 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.

HR-B

> 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 Total of all reporting groups

Baseline Measures
   HR-A   HR-B   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   19   77 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Full Range)
 68 
 (52 to 80) 
 69 
 (51 to 79) 
 68 
 (51 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      58 100.0%      19 100.0%      77 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   58   19   77 


  Outcome Measures

1.  Primary:   Acute Grade 3 or Higher Treatment-related Toxicity Rate.   [ Time Frame: 6 months after the completion of radiation therapy ]

2.  Secondary:   Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.   [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.   [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  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: Nancy P. Mendenhall, MD
Organization: University of Florida Health Proton Therapy Institute
phone: 904-588-1000
e-mail: 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.


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01040624     History of Changes
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 29, 2018