CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: March 27, 2018
End Date: May 01, 2019
- 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.
- 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).
- Prostatic Neoplasms