Short Course ADT for High Risk Low/Intermediate Risk ARTERA...

About this study

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.

Condition: Prostate Cancer
Tested: Androgen Deprivation Therapy (ADT), Radiotherapy
Sponsor: NYU Langone Health

Who can join

Age: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted

Inclusion 18

Minimum age: 18 years
Eligible sex: Male
Study condition: Prostate Cancer
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 16

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.

Where

1 site, 1 recruiting

NYU Langone Health

New York, New York, United States

Recruiting

Contact