Prostate Cancer
Conditions
Keywords
prostatectomy, radiation, neoadjuvant
Brief summary
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.
Interventions
RADIATIONRadiation
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes
PROCEDURERadical Prostatectomy
Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy. If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy. This surgical procedure will be performed by one of the standard accepted approaches.
Sponsors
Virginia Commonwealth University
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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, * age \> 18, * 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| post-operative morbidity | 30 day |
Secondary
| Measure | Time frame |
|---|---|
| continence | 1 year |
| erectile function | 1 year |
| biochemical recurrence | 2 years |
Countries
United States
Outcome results
None listed