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

University of Florida77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

< 15% risk of + LNRADIATION

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 + LNRADIATION

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Acute Grade 3 or Higher Treatment-related Toxicity Rate.

Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.

Time frame: 6 months after the completion of radiation therapy

Secondary Outcomes

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

Data from ClinicalTrials.gov

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