Prostate Cancer Clinical Trial

PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

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.

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Full 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.

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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.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT03663218

Recruitment Status:

Active, not recruiting

Sponsor:

Weill Medical College of Cornell University

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There is 1 Location for this study

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Weill Cornell Medicine
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT03663218

Recruitment Status:

Active, not recruiting

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

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