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

N/AActive Not RecruitingNCT03663218

Weill Medical College of Cornell University16 enrolled

Overview

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

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 including two parts. Part 1 will be a modified dose escalation and de-escalation study to determine maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) based on acute toxicity measures. Part 2 will be a cohort expansion study to further evaluate the safety and tolerability of the RP2D based on toxicities measured at 1 year. For Part 1, the primary endpoint is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative GU and/or GI grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days. For Part 2, the primary endpoint is to assess GU and/or GI grade 3 or higher toxicity based on CTCAE v5.0 at 1 year. The previously entered quality-of-life measure was removed to align the record with the primary and secondary endpoints as pre-specified in the IRB-approved protocol. Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

5 Gy x 5 fractionsRADIATION

In the arm "Part 1 - Arm 5 Gy x 5 fractions" the participants will receive a dose of 5 Gy for each RT fraction for a total of 5 fractions (total dose 25 Gy).

6 Gy x 5 fractionsRADIATION

In the arm "Part 1 - Arm 6 Gy x 5 fractions" the participants will receive a dose of 6 Gy for each RT fraction for a total of 5 fractions (total dose 30 Gy).

6.5 Gy x 5 fractionsRADIATION

In the arm "Part 1 - Arm 6.5 Gy x 5 fractions" the participants will receive a dose of 6.5 Gy for each RT fraction for a total of 5 fractions (total dose 32.5 Gy).

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Weill Cornell Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Number of Subjects Who Successfully Complete Radical Prostatectomy After SBRT Without a Post-operative DLT of Grade 3 or Higher (Part 1)

Part 1: Successful completion of radical prostatectomy after SBRT without a post-operative dose limiting toxicity (DLT) of grade 3 or higher within 1 month after prostatectomy according to the Clavien-Dindo Classification.

Time frame: 1 month

Number of Gastric-intestinal (GI) and/or Genitor-urinary (GU) Adverse Events Equal or Higher G3 Related to Preoperative Radiotherapy According to the CTCAE v5.0 Measured at 1 Year (Part 2)

Part 2: Successful completion of radical prostatectomy after SBRT without a post-operative DLT of grade 3 or higher within 1 year after prostatectomy.

Time frame: 1 year

Secondary Outcomes

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 (Part 2).

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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