Clinical trial NCT00969111: Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Official title: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Proton Radiation, Prostate Cancer
Lead sponsor: Proton Collaborative Group
Sponsor class: NETWORK
Collaborators: name: University of Florida Health
First posted: 2009-08-31
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
* Maximum PSA value of 20 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.

Primary outcomes:
measure: The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
timeFrame: 6 months after the end of radiation therapy
Secondary outcomes:
measure: Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters
timeFrame: After radiation: every 6 months for 3 years, then annually for 20 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
city: Warrenville
country: United States
facility: Northwestern Medicine Chicago Proton Center
state: Illinois
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Randal H Henderson, MD
role: PRINCIPAL_INVESTIGATOR
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