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Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Inclusion Criteria:

- Prostate cancer treated primarily with open, laparoscopic or robotically assisted

- Node negative pathologic T stage 2-3 of the prostate.

- Maximum PSA value of 2 ng/ml.

- At least one of the following risk factors as the indication for radiation:

If post-op radiotherapy:

- Extracapsular penetration

- Positive surgical margins

- Invasion of the seminal vesicles

- A persistently elevated post prostatectomy PSA (≥ 0.2 ng/ml < 6 weeks after
prostatectomy) in the absence of detectable distant metastasis

If salvage radiotherapy:

- Biopsy proven and/or radiographically defined local-regional relapse

- Biochemical relapse after a non-detectable post prostatectomy PSA (any detectable PSA
at least 6 weeks after prostatectomy followed by another higher value, or a single
PSA of 0.5 ng/ml or higher) in the absence of detectable distant metastases

- Patient must give study-specific informed consent on an IRB-stamped consent
prior to any research related procedures or study treatment.

- Patient must be at least 18 years old at the time of consent.

- Documented pathological TNM stage if this can be determined from prior records.

- Hemoglobin ≥ 10 g/dl within 3 months prior to study treatment.

- Alkaline phosphatase within 3 months prior to study treatment. If elevated,
patient must have clinical correlation to assess for metastases. (Plain x- ray,
CT, BALP and/or bone scan)

Exclusion Criteria:

- Pathologic T1 tumors.

- Evidence of distant metastasis (M1). If confirmatory imaging studies remain
equivocal, the patient is excluded unless biopsy of the questionable area is

- 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.

- Patients of child-producing potential not willing to use medically acceptable
contraception while on study treatment and for at least 12 months after study
treatment. Please document as such.

- Major medical, addictive and/or psychiatric illness which, in the investigator's
opinion, may prevent the consent process, completion of the study treatment and/or
interfere with follow-up.

- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use
during radiation.

Type of Study:


Study Design:

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

Outcome Measure:

The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.

Outcome Time Frame:

6 months after the end of radiation therapy

Safety Issue:


Principal Investigator

Randal H Henderson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute


United States: Institutional Review Board

Study ID:

UFPTI 0902-PR06



Start Date:

August 2009

Completion Date:

August 2050

Related Keywords:

  • Prostate Cancer
  • Proton Radiation, Prostate Cancer
  • Prostatic Neoplasms



University of Florida Proton Therapy Institute Jacksonville, Florida  32206