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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2013
• Main ID: NCT00969111
• Date of registration: 28/08/2009
• Primary sponsor: University of Florida
• Public title: Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy PR06
• Scientific title: Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
• Date of first enrolment: August 2009
• Target sample size: 70
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00969111
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Intake Coordinator

• Name: Intake Coordinator

• Name: Randal H Henderson, MD
• Affiliation: University of Florida Proton Therapy Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- 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
negative.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Radiation: Proton (prostate bed) to 70.2 CGE

Radiation: Proton to 66.6 CGE

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

UFPTI 0902-PR06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors