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

This study has been withdrawn prior to enrollment.
(poor accrual)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00691977
First received: June 3, 2008
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: Radiation Therapy followed by prostatectomy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Evaluate number of patients who are able to undergo surgery after preoperative radiation therapy. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: September 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Radiation Therapy followed by prostatectomy
Radiation: Radiation Therapy followed by prostatectomy
Radiation Therapy

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.

  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691977

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Mitchell S. Anscher, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00691977     History of Changes
Other Study ID Numbers: Duke-10571
Study First Received: June 3, 2008
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Radiation Therapy

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014