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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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