Preoperative Radiation Therapy for High Risk Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Duke University
Collaborator:
Virginia Commonwealth University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01041326
First received: December 30, 2009
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical prostatectomy for patients with high-risk localized disease. Its hypothesis is that such treatment will be well tolerated with similar side effect profile as surgery alone. Patients in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), 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 patient will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: Radiation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group 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 Duke University:
Primary Outcome Measures:
- post-operative morbidity [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- continence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- erectile function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- biochemical recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation
Single arm dose escalation of prostate/pelvis radiation up to 54 Gy
|
Radiation: Radiation
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041326
Locations
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
Duke University
Virginia Commonwealth University
Investigators
| Principal Investigator: | Bridget F Koontz, MD | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01041326 History of Changes |
| Other Study ID Numbers: | Pro00006510 |
| Study First Received: | December 30, 2009 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
prostatectomy radiation neoadjuvant |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013