Clinical trial NCT03663218: PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
Official title: PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.

Detailed description: Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single arm study and the primary objectives is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days. Secondary objectives are to assess acute toxicity and quality of life scores. Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.

Eligibility criteria: Inclusion Criteria:

* Men aged greater than equal to18 with histologically confirmed primary prostate cancer.
* KPS greater than equal to 70
* Patient with a negative staging bone scan.
* Patient can undergo an MRI.
* Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short axis. Documented negative biopsy of suspicious node required.
* Patient is medically fit to undergo prostatectomy.
* Patient has either Gleason Score greater than equal to 8 on biopsy and/or clinical/radiographic evidence of T3 disease.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of subjects who successfully complete radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher
timeFrame: 1 month
Secondary outcomes:
measure: Acute toxicity in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be assessed based on NCI Common terminology criteria for adverse events (CTCAE) version 5.0.
timeFrame: 3 months
measure: Quality of life scores in patients after stereotactic body radiotherapy (SBRT) and radical prostatectomy (RP) will be collected.
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Cornell Medicine - New York Presbyterian Hospital
name: Silvia C. Formenti, M.D.
role: PRINCIPAL_INVESTIGATOR
References: