Clinical trial NCT01041326: Preoperative Radiation Therapy for High Risk Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostatectomy
radiation
neoadjuvant
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
First posted: 2009-12-31
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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,
* 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.

Primary outcomes:
measure: post-operative morbidity
timeFrame: 30 day
Secondary outcomes:
measure: continence
timeFrame: 1 year
measure: erectile function
timeFrame: 1 year
measure: biochemical recurrence
timeFrame: 2 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Duke University
name: Bridget F Koontz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koontz BF, Quaranta BP, Pura JA, Lee WR, Vujaskovic Z, Gerber L, Haake M, Anscher MS, Robertson CN, Polascik TJ, Moul JW. Phase 1 trial of neoadjuvant radiation therapy before prostatectomy for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):88-93. doi: 10.1016/j.ijrobp.2013.05.014. Epub 2013 Jun 19.