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


Phase 1
18 Years
70 Years
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


Inclusion Criteria:



Subjects must have

- biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA > 20, 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.

- a negative bone scan,

- be medically fit to undergo surgery as determined by treating urologist,

- under 70 years of age,

- KPS must be >/= 80,

- no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,

- no prior invasive malignancy, except non- melanomatous skin cancer unless disease
free for a minimum of 5 years. Carcinoma in-situ of the bladder or head and neck
region is permissible.

- Subjects must freely sign informed consent to enroll in the study.

Exclusion Criteria:

- prior pelvic radiation therapy, chemotherapy, or androgen deprivation,

- prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of
the bladder or head and neck region, unless disease free for a minimum of 5 years.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

post-operative morbidity

Outcome Time Frame:

30 day

Safety Issue:

Yes

Principal Investigator

Bridget F Koontz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00006510

NCT ID:

NCT01041326

Start Date:

April 2005

Completion Date:

February 2014

Related Keywords:

  • Prostate Cancer
  • prostatectomy
  • radiation
  • neoadjuvant
  • Prostatic Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
Virginia Commonwealth UniversityRichmond, Virginia