Short Course ADT for High Risk Low/Intermediate Risk ARTERA Prostate Cancer

A Phase II Prospective Trial Utilizing Short Course Androgen Deprivation Therapy In Conjunction With Ultra-Hypofractionated SBRT For High Risk Nccn Prostate Cancer With Lower Risk Artera Scores

For this study, high risk prostate cancer patients with lower risk ARTERA scores will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. Specifically, patients enrolled in this study will undergo one of several dose-escalated forms of radiotherapy which would include SBRT with or without a brachytherapy boost.

Inclusion Criteria:

• Ability to understand and willingness to sign a written informed consent document
• 18 years of age or older male participants
• Biopsy proven prostate cancer meeting at least one of the following high-risk criteria: Gleason score 8-10 OR; Baseline PSA >20 up to and including 40 ng/ml OR; Patients with Gleason score 6-7 remain eligible if the PSA criterion (>20 ng/mL) is met OR; MRI Radiographic stage T1-T3 disease without evidence of nodal involvement
• No imaging evidence of nodal metastases on baseline MRI/ CT of the pelvis and PET-PSMA scans
• Low risk or intermediate risk ARTERA AI scores
• Serum testosterone ≥ 120 ng/dL determined prior to ADT start
• At least 4 weeks must have elapsed from major surgery
• Karnofsky Performance Status (KPS) > 80
• Prostate size < 90 cc
• MRI findings: Lesion may have extracapsular extension (ECE)
• International Prostate Symptom Score (IPSS) < 22
• Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Exclusion Criteria:

• Gleason score 6 or 7 in the absence of PSA >20 ng/mL
• PSA >40 ng/mL
• Prior or concurrent androgen deprivation therapy for prostate cancer of >3 months duration
• High Risk ARTERA scores
• MRI findings: suspicious nodal metastases
• Evidence of regional lymphadenopathy or metastatic disease on MRI/CT or PSMA PET scan
• Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
• Contra-indications to receiving gadolinium contrast
• KPS < 80
• Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T4, or N1 disease or bone disease
• Prior treatment for prostate cancer, including history of chemotherapy or surgery for prostate cancer (except for prior [transurethral resection of prostate] TURP or greenlight [photo selective vaporization of prostate] PVP which would be allowed)
• History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years. Patients with Crohn's disease or ulcerative colitis
• IPSS > 22
• Currently on any ARPis (including but not limited to: enzalutamide, apalutamide, darolutamide, or abiraterone)
• Prior pharmacologic androgen deprivation therapy (ADT) for prostate cancer is permitted under the following (2) conditions: 1) Participants meeting this criterion will be assigned to a separate stratum within each primary treatment cohort. 2) Patients remain eligible for enrollment provided they have received no more than 3 months of ADT in total, regardless of whether ADT was initiated before screening or registration.