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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

Tracking Information
First Submitted Date  ICMJE December 24, 2009
First Posted Date  ICMJE December 29, 2009
Results First Submitted Date  ICMJE June 25, 2015
Results First Posted Date  ICMJE July 22, 2015
Last Update Posted Date June 5, 2019
Study Start Date  ICMJE December 2009
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 24, 2009)
Collect and analyze morbidity outcomes. The rate of (6 month) > grade 3 gastrointestinal (GI) and genitourinary (GU) toxicity following treatment with proton based therapy. [ Time Frame: Weekly during radiation treatment then every 6 months for 3 years, then annually ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2009)
  • Collect and analyze quality of life, disease control and survival outcome parameters. [ Time Frame: Within 2 months prior to study treatment, then every 6 months for 3 years, then annually ]
  • Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes. [ Time Frame: Every 6 months ]
  • Develop a tissue database comprised of a subset of patients who have had a biopsy performed at Shands, for future permission to study tissue and correlate the information with outcomes [ Time Frame: Every 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
Official Title  ICMJE 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
Brief Summary The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: High-risk arm A (HR-A)
    < 15% risk of + lymph nodes (LN)
    Intervention: Radiation: < 15% risk of + LN
  • Experimental: HR-B
    > 15% risk of + LN
    Intervention: Radiation: > 15% risk of + LN
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 25, 2015)
77
Original Estimated Enrollment  ICMJE
 (submitted: December 24, 2009)
53
Estimated Study Completion Date  ICMJE January 2035
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

* Adenocarcinoma of the prostate.

Exclusion Criteria:

  • Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
  • Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
  • History of hip replacement.
  • Prior intrapelvic surgery. This includes the following:
  • Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
  • Transabdominal pelvic surgery
  • Bladder surgery
  • Prior myocardial infarction (MI) or congestive heart failure (CHF).
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01040624
Other Study ID Numbers  ICMJE UFPTI 0703 - PR05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nancy P Mendenhall, MD University of Florida Proton Therapy Institute
PRS Account University of Florida
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP