Preoperative Radiation Therapy for High Risk Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041326
• Other study ID #: Pro00006510
• Status: Completed
• Phase: Phase 1
• First received: December 30, 2009
• Last updated: July 16, 2013
• Start date: April 2005
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiation
Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes

Procedure:
• Radical 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative morbidity		30 day	Yes
Secondary	continence		1 year	Yes
Secondary	erectile function		1 year	No
Secondary	biochemical recurrence		2 years	No