Radiation Therapy Followed by Surgery in High-Risk, Localized Carcinoma of the Prostate

April 23, 2013 updated by: Virginia Commonwealth University

A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk, Localized Carcinoma of the Prostate

The purpose of the study is to assess the safety of four different doses of radiation therapy followed by to surgery to remove prostate tumor.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fraction), respectively, to the whole pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy, respectively. The patients will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
  • Subjects must have a negative bone scan.
  • Subjects must have "high-risk" prostate cancer, defined as:

A. PSA >/= 20, and/or B. Gleason Score (GS) >/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or clinical stage = T2b / T2c.

  • Subjects must be medically fit to undergo surgery as determined by treating urologist.
  • Subjects must be under 70 years of age.
  • KPS must be >/= 80.
  • Subjects must not have a synchronous primary tumor, or a previous cancer unless disease free for >/= 5 years.
  • Subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen deprivation.
  • Subjects must freely sign informed consent to enroll in the study.

Exclusion Criteria:

  • Metastatic disease as demonstrated by bone scan, CT scan or MRI of the pelvis, or chest x-ray.
  • Pathologically documented positive pelvic lymph nodes. If Pre-operative CT scan or MRI (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
  • Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
  • History of prior pelvic radiation therapy.
  • History of androgen deprivation therapy or chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Radiation Therapy followed by prostatectomy
Radiation: Radiation Therapy followed by prostatectomy
Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate number of patients who are able to undergo surgery after preoperative radiation therapy.
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Mitchell S. Anscher, M.D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Duke-10571

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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