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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: < 15% risk of + LN Radiation: > 15% risk of + LN||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2035|
Experimental: High-risk arm A (HR-A)
< 15% risk of + lymph nodes (LN)
Radiation: < 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
Radiation: > 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.
- Acute Grade 3 or Higher Treatment-related Toxicity Rate. [ Time Frame: 6 months after the completion of radiation therapy ]Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040624
|United States, Florida|
|University of Florida Proton Therapy Institute|
|Jacksonville, Florida, United States, 32206|
|Principal Investigator:||Nancy P Mendenhall, MD||University of Florida Proton Therapy Institute|