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NCT Number: NCT05169970

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiation Therapy (SBRT)

Radiation

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.

Primary outcomes

  1. Rate of biochemical progression free survival

    Time frame: 2 years

    Biochemical progression will be determined according to the established criteria of 2 ng/nl elevation of the PSA nadir level (nadir + 2 definition).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2021
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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