CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation

ID#: NCT03657108

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: March 27, 2018

End Date: May 01, 2019

Contact Information:
Kennedy E Okhawere, MD, MPH
Summary: A phase I single-arm open label dose escalation study to evaluate the maximum tolerated dose (MTD) and safety of Civasheet® with radical prostatectomy (RP) and adjuvant external beam radiation therapy (EBRT) in a 3+3 dose escalation design among participants with high risk prostate cancer (PCa).

Inclusion Criteria:

- Any subject with National Comprehensive Cancer Network (NCCN) very high or high risk adenocarcinoma of the prostate defined as ≥T3a, Gleason score ≥ 8, or PSA > 20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option.

- Any subject with NCCN Intermediate Risk adenocarcinoma of the prostate defined as T2b-T2c, Gleason score 7, or PSA 10-20 who is eligible for RP (open or robotic) with adjuvant EBRT as an initial treatment option and at least one of the following adverse features present in pre-operative imaging: seminal vesicle infiltration (SVI), extracapsular extension (ECE), N1 disease.

- Subject must have had a pre-operative MRI or must obtain a pre-operative MRI to be eligible for participation in this study.

- Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

- Any subject who has undergone prior radiation to the pelvis.

- Subjects presenting with distant metastases.

- On any investigational drug(s), androgen deprivation therapy or therapeutic device(s) within 30 days preceding screening.

- Currently taking immunosuppressants, or with poorly controlled diabetes (HbA1c >8).