Prostate Cancer
Conditions
Keywords
high-risk prostate cancer
Brief summary
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.
Interventions
DRUGAndrogen Deprivation Therapy (ADT)
ADT will be delivered with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.
RADIATIONRadiotherapy
Dose-escalated radiotherapy.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-Year Cumulative Incidence of Distant Metastases | Up to Year 5 | Incidence of distant metastases (DM). DM is defined as the first occurrence of radiographic or biopsy-confirmed distant metastatic disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short-Form-12 (SF-12) Score | Baseline, Year 2 | 12-item assessment of health and quality of life. Each item is rated on a Likert scale. The raw score is the sum of responses and is converted to a standard score between 0-100; higher scores indicate better quality of life. |
| Change in International Prostate Symptom Score (IPSS) Score | Baseline, Year 2 | 7-item assessment of the severity of lower urinary tract symptoms linked to benign prostatic hyperplasia (BPH). Each item is rated on a Likert scale. The total score is the sum of responses and ranges from 0-35; lower scores indicate milder symptoms. |
| Time to Biochemical Failure | Up to Year 5 | Time to biochemical failure will be measured from study enrollment to the date when the Phoenix criterion (PSA nadir + 2 ng/mL) is first met. |
| Overall Survival (OS) | Up to Year 5 | Defined as the time from study enrollment to death from any cause. |
| Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score | Baseline, Year 2 | 26-item survey assessing prostate cancer-related symptom domains. Each item is rated on a Likert score. The raw score is the sum of responses and is converted to a standard score from 0-100, where higher scores indicate greater quality of life. |
| Distant Metastasis-Free Survival (DMFS) | Up to Year 5 | Defined as the time from study enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first. |
Countries
United States
Contacts
CONTACTNina Yang, RN
PRINCIPAL_INVESTIGATORMichael Zelefsky, MD
NYU Langone Health
Outcome results
None listed