Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
NCT ID: NCT01040624
Last Updated: 2023-10-03
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
77 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-12-31
Study Completion Date
2022-04-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Prostate Cancer
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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High-risk arm A (HR-A)
\< 15% risk of + lymph nodes (LN)
Group Type
EXPERIMENTAL
< 15% risk of + LN
Intervention Type
RADIATION
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
Group Type
EXPERIMENTAL
> 15% risk of + LN
Intervention Type
RADIATION
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.
Interventions
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< 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.
Intervention Type
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.
Intervention Type
RADIATION
Eligibility Criteria
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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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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University of Florida
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Nancy P Mendenhall, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida Proton Therapy Institute
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Site Status
Countries
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United States
References
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Other Identifiers
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IRB201702459
Identifier Type: OTHER
Identifier Source: secondary_id
UFPTI 0703 - PR05
Identifier Type: -
Identifier Source: org_study_id
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Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
NCT00348816
TERMINATED
PHASE2
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
NCT00133224
TERMINATED
PHASE3
Proton Therapy for High Risk Prostate Cancer
NCT01811810
WITHDRAWN
NA
A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer
NCT01957436
ACTIVE_NOT_RECRUITING
PHASE3
Adjuvant Chemotherapy for High Malignant Prostate Cancer
NCT06864533
RECRUITING
NA
Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer
NCT01039038
TERMINATED
PHASE2
Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer
NCT03432780
UNKNOWN
PHASE2
Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
NCT01023061
COMPLETED
PHASE2
Comparison of High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy for the Treatment of Localized Prostate Cancer
NCT04253483
ACTIVE_NOT_RECRUITING
PHASE2