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

Description

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

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * Radiographic T3-T4 detected on staging mpMRI
  • * 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

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Daniel Gorovets, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2024-12