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

Last updated: May 7, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Urologic Cancer

Treatment

Stereotactic Body Radiation Therapy (SBRT)

Clinical Study ID

NCT05169970
21-458
  • Ages > 18
  • Male

Study 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

Inclusion Criteria:

  • Pathologically proven diagnosis of prostate adenocarcinoma within 12 months ofenrollment

  • Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratificationguidelines, 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 andRelease of Health and Research Study Information (HIPAA authorization)

Exclusion

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 hormonaltherapy

  • Prior pelvic radiation

  • Active second malignancy or past history of malignancies diagnosed within the last 2years that requires active therapy and/or in remission, with the exception ofresected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I headand neck cancer, or stage I colorectal cancer

  • TURP or greenlight PVP within 6 months of enrollment

  • History of Crohn's Disease or Ulcerative Colitis

Study Design

Total Participants: 215
Treatment Group(s): 1
Primary Treatment: Stereotactic Body Radiation Therapy (SBRT)
Phase: 2
Study Start date:
December 09, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memoral Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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