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

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy (SBRT)

• Registration Number: NCT05169970
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-09
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with high risk Decipher scores	Stereotactic Body Radiation Therapy (SBRT)	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).
Patients with low-intermediate risk Decipher scores	Stereotactic Body Radiation Therapy (SBRT)	Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).

Primary Outcome Measures

Name	Time	Method
Rate of biochemical progression free survival	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).

Trial Locations

Locations (7)

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

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

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