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

Sponsored by:	Virginia Commonwealth University
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00691977

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 I

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	24
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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

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

Contacts

Contact: Mitchell S. Anscher, M.D.	804-828-7238	manscher@mcvh-vcu.edu
Contact: Diane J. Holdford, R.N.	804-828-0296	djholdfo@vcu.edu

Locations

United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23219
Principal Investigator: Mitchell S. Anscher, M.D.

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator:

Mitchell S. Anscher, M.D.

Virginia Commonwealth University

More Information

Responsible Party:	Virginia Commonwealth University ( Mitchell Anscher, MD )
Study ID Numbers:	Duke-10571
Study First Received:	June 3, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00691977
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Radiation Therapy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009