Radiation Therapy Followed by Surgery in High-Risk, Localized Carcinoma of the Prostate
This study has been withdrawn prior to enrollment.
(poor accrual)
Sponsor:
Virginia Commonwealth University
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
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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
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 May 23, 2013