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

NCT00691977 | Withdrawn Phase 1

• 1 other identifier: Duke-10571
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Radiation Therapy

Outcome Measures

Primary Outcomes (1)

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

  4 months

Study Arms (1)

A

EXPERIMENTAL

Radiation Therapy followed by prostatectomy

Radiation: Radiation Therapy followed by prostatectomy

Interventions

Radiation Therapy followed by prostatectomy RADIATION

Radiation Therapy

A

Eligibility Criteria

• Age: Up to 69 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mitchell S. Anscher, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 6, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

US (1)