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PreOperative RadioTherapy for High-Risk Prostate Cancer (PORT-PC Trial)

Clinical Trial Details

The purpose of this study is to determine if patients can undergo a radical prostatectomy (surgery to remove prostate gland and surrounding tissues) after Stereotactic Body Radiotherapy (SBRT, highly potent biological dose of radiation is delivered to the tumor in fewer treatments) without any major side effects to the gastrointestinal or urinary systems. 

This research study is being done to identify the maximum tolerated dose of radiation that can be delivered safely to the patients before they undergo radical prostatectomy. This is a dose escalation study where first 3 patients receive 5 Gy of radiation for 5 fractions (days). They are assessed for major side effects after radiation treatment and surgery. If there are no major side effects within 30 days after surgery, another set of 3 patients are recruited who undergo 6 Gy x 5 fractions of radiation therapy. This is repeated at dose levels 7 Gy x 5 fractions and 8 Gy x 5 fractions. If at any dose level, the patients experience a major side effect within 30 days after surgery the trial will accrue the next set of patients to the previously tolerated lower dose. 

Key Eligibility: 

Inclusion Criteria 

  • Men aged 18 years and up with histologically confirmed primary prostate cancer 
  • Patient with a negative staging bone scan
  • Patient can undergo an MRI
  • Patient is medically fit to undergo prostatectomy 

Exclusion Criteria 

  • Prior history of receiving androgen deprivation therapy 
  • Prior history of receiving chemotherapy 
  • Prior history of receiving pelvic radiotherapy 
  • Patient is unwilling to undergo prostatectomy 
  • Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sharanya Chandrasekhar
(646) 962-2196
shc2043@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1712018849

ClinicalTrials.gov:

NCT03663218

Status

Open to Enrollment

Age Group

Adult

Sponsor