IRB Study Number 22-012
Status Recruiting
Location Akron General
Institute Taussig Cancer Institute
Description
2.1 Primary Objective
Determine the association between HSD3B1 genotype and rate of PSA response (PSA <0.5ng/ml) to neoadjuvant ADT (3 months GnRH Agonist, e.g. leuprolide 22.5mg IM)
2.2 Secondary Objective(s)
Determine whether an association exists between HSD3B1 genotype and:
o End of treatment PSA (completion of ADT)
o Time to initiation of 2nd line therapy
o BRFS
o MFS
o OS
2.3 Exploratory Objectives (s)
Feasibility of HSD3B1 genotyping in HR PCa
Inclusion Criteria
4.1.1 Subjects must have histologically or cytologically confirmed adenocarcinoma of the prostate and must fall into at least unfavorable intermediate risk group as defined by:
GG3 (any core Gleason 4+3) and T1-T2 and PSA <20ng/ml or
GG4-5 (any core Gleason 4+4, 4+5, 5+4, 5+5) or T3 or PSA > 20 ng/ml
N1 due to metastases in regional lymph node(s)
Low-volume metastatic disease, defined as men with M1 disease not fitting the following definition of high-volume disease: 4 or more bone metastases (with at least 1 outside the pelvis/vertebral bodies) or any visceral metastases.
4.1.2 Subjects must have received no prior curative intent therapies for prostate cancer.
(Includes prior androgen deprivation therapy, radiotherapy, or surgery.)
4.1.3 Age >18 years.
Because prostate cancer is generally diagnosed in adults and no dosing or adverse event data are currently available on the use of ADT in combination with external beam radiation in subjects ≤18 years of age, children are excluded from this study.
4.1.4 Performance status [See Appendix A].
ECOG Performance status ≤2
Karnofsky Performance status ≥70%
4.1.5 Life expectancy of ≥5 years, in the opinion of and as documented by the investigator.
4.1.10 Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
4.2.1 Prior curative intent treatment for prostate cancer.
4.2.2 Subjects receiving any other investigational agents.
4.2.3 History of allergic reactions attributed to compounds of similar chemical or biologic composition to any ADT therapeutic agents.
4.2.4 Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, refractory cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
4.2.5 Any prior pelvic radiotherapy
