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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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy (SBRT)

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Unfavorable Intermediate-Risk Prostate Cancer, Stereotactic Body Radiation Therapy (SBRT), 21-458

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with low-intermediate risk Decipher scores

Patients with high risk Decipher scores

Arm Description

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).

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).

Outcomes

Primary Outcome Measures

Rate of biochemical progression free survival

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05169970

First Posted

December 9, 2021

Last Updated

October 5, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05169970

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Unfavorable Intermediate-Risk Prostate Cancer, Stereotactic Body Radiation Therapy (SBRT), 21-458

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

215 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with low-intermediate risk Decipher scores

Arm Type

Experimental

Arm Description

Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).

Arm Title

Patients with high risk Decipher scores

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Intervention Description

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 Measure Information:

Title

Rate of biochemical progression free survival

Description

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

Time Frame

2 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Gorovets, MD

Phone

212-639-3983

gorovetd@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Marisa Kollmeier, MD

Phone

212-639-3952

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Phone

212-639-3983

Facility Name

Memorial Sloan Kettering Monmouth (All Protocol Activities)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Phone

212-639-3983

Facility Name

Memorial Sloan Kettering Bergen (All Protocol Activities)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Phone

212-639-3983

Facility Name

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Phone

212-639-3983

Facility Name

Memorial Sloan Kettering Westchester (All Protocol Activities)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Phone

212-639-3983

Facility Name

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Phone

212-639-3983

Facility Name

Memorial Sloan Kettering Nassau (All Protocol Activities)

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Gorovets, MD

Phone

212-639-3983

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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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