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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05169970
• Collaborator: (none)
• Enrollment: 145
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 35.7
• Patients Per Site: 20.7
• Patients Per Site Per Month: 0.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Stereotactic Body Radiation Therapy (SBRT); Radiation: Stereotactic Body Radiation Therapy (SBRT)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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.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: Dec 9, 2021
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York	United States	11553

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Michael Zelefsky, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT05169970
• Other Study ID Numbers: 21-458
• First Posted: Dec 27, 2021
• Last Update Posted: Feb 24, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Prostatic Neoplasms

Study Results

No Results Posted as of Feb 24, 2022