Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer (PR05)

University of Florida

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: < 15% risk of + LN; Radiation: > 15% risk of + LN

Study type: Interventional

Funder types: Other

Identifiers

NCT01040624

IRB201702459 (Other Identifier)

UFPTI 0703 - PR05

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

High-risk arm A (HR-A)

Experimental group

Description:

\< 15% risk of + lymph nodes (LN)

Treatment:

Radiation: < 15% risk of + LN

HR-B

Experimental group

Description:

\> 15% risk of + LN

Treatment:

Radiation: > 15% risk of + LN