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

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy followed by prostatectomy
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Radiation Therapy

Eligibility Criteria

undefined - 69 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Radiation Therapy followed by prostatectomy

Outcomes

Primary Outcome Measures

Evaluate number of patients who are able to undergo surgery after preoperative radiation therapy.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2008
Last Updated
April 23, 2013
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT00691977
Brief Title
Radiation Therapy Followed by Surgery in High-Risk, Localized Carcinoma of the Prostate
Official Title
A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk, Localized Carcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
poor accrual
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Radiation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Radiation Therapy followed by prostatectomy
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy followed by prostatectomy
Intervention Description
Radiation Therapy
Primary Outcome Measure Information:
Title
Evaluate number of patients who are able to undergo surgery after preoperative radiation therapy.
Time Frame
4 months

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S. Anscher, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

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

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