A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer

Study Overview
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Brief Summary
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The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments

Official Title
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A Phase II Study of Decipher-Guided Dose Escalated Radiation Therapy In Unfavorable Intermediate Risk Prostate Cancer Patients Treated SBRT Alone Without Androgen Deprivation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy (SBRT)
* Radiation: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features: Gleason Score 4+3 ≥ 50% biopsy cores positive Two or more of the following risk factors: Grade Group 2 or 3 cT2b-T2c PSA 10 - 20 ng/mL Able to undergo MRI for initial staging and MR based radiation planning Sufficient biopsy tissue available for Decipher genomic testing Prostate volume < 90cc IPSS ≤ 20 Age ≥ 18 KPS ≥ or ECOG 0-2 Estimated life expectancy >5 years Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) Exclusion Criteria: Radiographic T3-T4 detected on staging mpMRI °Must be consistent with (>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist. Evidence of distant metastases as determined by MRI, PET, or CT imaging Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy Prior pelvic radiation Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer TURP or greenlight PVP within 6 months of enrollment History of Crohn's Disease or Ulcerative Colitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a phase II nonrandomized noninferiority trial that aims to evaluate the efficacy of dose escalated radiation therapy in the absence of androgen deprivation therapy for Decipher genomic score stratified NCCN unfavorable intermediate risk prostate cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with low-intermediate risk Decipher scores<br>Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions). | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Patients with a low or intermediate risk Decipher score will receive radiation targeting the seminal prostate and seminal vesicles to a dose of 40 Gy in 5 fractions delivered every other day.<br>|
| Experimental: Patients with high risk Decipher scores<br>Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions) with a boost of up to 45Gy to the dominant intraprostatic lesion as identified on pretreatment MRI plus hypofractionated pelvic EBRT (25Gy in 5 fractions). | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Patients with high risk Decipher scores will receive radiation targeting the prostate and seminal vesicles to a dose of 40 Gy in 5 fractions with a simultaneous integrated boost to 45 Gy of any dominant intraprostatic lesion as well as radiation to the pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered every other day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of biochemical progression free survival | Biochemical progression will be determined according to the established criteria of 2 ng/nl elevation of the PSA nadir level (nadir + 2 definition). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unfavorable Intermediate-Risk Prostate Cancer, Stereotactic Body Radiation Therapy (SBRT), 21-458