Preoperative Radiation Therapy for High Risk Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Virginia Commonwealth University
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01041326
First received: December 30, 2009
Last updated: July 16, 2013
Last verified: July 2013
  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
Procedure: Radical Prostatectomy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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 ]

Enrollment: 15
Study Start Date: April 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Leve 1 Radiation
Subjects in Group 1 will receive 39.6 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
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.
Experimental: Level 2 Radiation
Subjects in Group 2 will receive 45 Gy (at 1.8 Gy/fx) to the whole pelvis. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
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.
Experimental: Level 3 Radiation
Subjects in Group 3 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
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.
Experimental: Level 4 Radiation
Subjects in Group 4 will receive 45 Gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 54 Gy. The subject will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.
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.

  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,
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01041326     History of Changes
Other Study ID Numbers: Pro00006510
Study First Received: December 30, 2009
Last Updated: July 16, 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 July 31, 2014