RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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.

Study sites (1)

NY