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

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.

Eligibility

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.

Conditions2

Interventions1

Locations1 site

Find trials near these locations

Related trials

• A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer — University College, London
• Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial) — German Oncology Center, Cyprus
• Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery. — CHU de Quebec-Universite Laval
• PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer — Affidea Nu-med Center of Oncological DIagnostics and Therapy
• PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer — Affidea Nu-med Center of Oncological DIagnostics and Therapy
• Radiotherapy After Prostatectomy for Node Positive Prostate Cancer — Sun Yat-sen University
• Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Browse More Trials