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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169970
• Other study ID #: 21-458
• Status: Recruiting
• Phase: Phase 2
• Start date: December 9, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Daniel Gorovets, MD
• Phone: 212-639-3983
• Email: gorovetd[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 years

External Links

•   Memorial Sloan Kettering Cancer Center