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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00691977
Recruitment Status : Withdrawn (poor accrual)
First Posted : June 6, 2008
Last Update Posted : April 24, 2013
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation Therapy followed by prostatectomy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: A
Radiation Therapy followed by prostatectomy
Radiation: Radiation Therapy followed by prostatectomy
Radiation Therapy

Primary Outcome Measures :
  1. Evaluate number of patients who are able to undergo surgery after preoperative radiation therapy. [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00691977

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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
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Principal Investigator: Mitchell S. Anscher, M.D. Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University Identifier: NCT00691977    
Other Study ID Numbers: Duke-10571
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013
Keywords provided by Virginia Commonwealth University:
Radiation Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases