Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy (PR06)

This study is currently recruiting participants.
Verified January 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00969111
First received: August 28, 2009
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.


Condition Intervention Phase
Prostate Cancer
Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Radiation: Proton (prostate bed) to 70.2 CGE
Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Radiation: Proton to 66.6 CGE
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy. [ Time Frame: 6 months after the end of radiation therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters [ Time Frame: After radiation: every 6 months for 3 years, then annually for 20 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: August 2009
Estimated Study Completion Date: August 2050
Estimated Primary Completion Date: August 2031 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postop Non-High Risk
Proton to 66.6 CGE
Radiation: Proton to 66.6 CGE
Post-Op Non High Risk
Experimental: Postop High Risk
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Postop High Risk
Experimental: Salvage Non-High Risk
Proton to 70.2 CGE
Radiation: Proton (prostate bed) to 70.2 CGE
Salvage Non-High Risk
Experimental: Salvage High Risk
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Salvage High Risk

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
  • Maximum PSA value of 2 ng/ml.

Exclusion Criteria:

  • Evidence of distant metastasis (M1).
  • Prior systemic chemotherapy for any reason.
  • Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • History of hip replacement.
  • Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969111

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Randal H Henderson, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Randal H Henderson, MD University of Florida Proton Therapy Institute
  More Information

Additional Information:
Publications:
Thompson IM, Tangen CM, Paradelo J, Lucia MS et al. Adjuvant Radiotherapy for Pathological T3N0M0 Prostate Cancer Significantly Reduces Risk of Metastases and Improves Survival: Long-Term Follow-up of a Randomized Clinical Trial. The Journal of Urology 2009: 181, 956-962.
King CR, Kapp DS. Radiotherapy After Prostatectomy: Is the Evidence for Dose Escalation Out There? Int. J. Radiation Oncology Biol. Phys. 2008; 71(2): 346-350.

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00969111     History of Changes
Other Study ID Numbers: UFPTI 0902-PR06
Study First Received: August 28, 2009
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Proton Radiation, Prostate Cancer

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 April 17, 2014