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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 20, 2014
Last verified: May 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
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: 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: May 20, 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 October 02, 2014