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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: < 15% risk of + LN; Radiation: > 15% risk of + LN

• Registration Number: NCT01040624
• Lead Sponsor: University of Florida

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 available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-24
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-29
• Primary Completion: 2015-01
• Results First Submitted: 2015-06-25
• Results First Submitted QC: 2015-06-25
• Results First Posted: 2015-07-22
• Study Completion: 2022-04-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-risk arm A (HR-A)	< 15% risk of + LN	\< 15% risk of + lymph nodes (LN)
HR-B	> 15% risk of + LN	\> 15% risk of + LN

Primary Outcome Measures

Name	Time	Method
Acute Grade 3 or Higher Treatment-related Toxicity Rate.	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.

Secondary Outcome Measures

Name	Time	Method
Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.	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.	After radiation: every 6 months for 3 years, then annually for 20 years

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States