Clinical trial NCT05169970: A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Unfavorable Intermediate-Risk Prostate Cancer
Stereotactic Body Radiation Therapy (SBRT)
21-458
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 215
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of biochemical progression free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniel Gorovets, MD
role: PRINCIPAL_INVESTIGATOR
References: