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

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ClinicalTrials.gov Identifier: NCT05169970
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Stereotactic Body Radiation Therapy (SBRT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 9, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Experimental: Patients with high risk Decipher scores
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).
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Patients with high risk Decipher scores will receive radiation targeting the prostate and seminal vesicles to a dose of 40 Gy in 5 fractions with a simultaneous integrated boost to 45 Gy of any dominant intraprostatic lesion as well as radiation to the pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered every other day.




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169970


Contacts
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Contact: Michael Zelefsky, MD 212-639-6802 zelefskm@mskcc.org
Contact: Marisa Kollmeier, MD 212-639-3952

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael Zelefsky, MD    212-639-6802      
Memoral Sloan Kettering Monmouth (All Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Bergen (All Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Michael Zelefsky, MD    212-639-6802      
United States, New York
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Andrew Zelenetz, MD    212-639-2656      
Memorial Sloan Kettering Westchester (All Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Michael Zelefsky, MD    212-639-6802      
Principal Investigator: Michael Zelefsky, MD         
Memorial Sloan Kettering Nassau (All Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Michael Zelefsky, MD    212-639-6802      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05169970    
Other Study ID Numbers: 21-458
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Unfavorable Intermediate-Risk Prostate Cancer
Stereotactic Body Radiation Therapy (SBRT)
21-458
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases