Skip to main content
OpenTrials
Completed

NCT Number: NCT01040624

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

< 15% risk of + LN

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.

> 15% risk of + LN

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.

Primary outcomes

  1. Acute Grade 3 or Higher Treatment-related Toxicity Rate.

    Time frame: 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma

Acronym: PR05

Important dates

Study start
2009
Primary completion
2015
Study completion
2022
First posted
Dec 29, 2009
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.