1/Focal SBRT for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+2 MoreStereotactic Body Radiation Therapy - Radiation
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

Background: The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments. Objective: To see how people with untreated localized prostate cancer will respond to focal therapy with SBRT. Eligibility: People aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland). Design: Participants will undergo screening including blood tests, an MRI, a PSMA PET/CT (18F-DCFPyL), and a biopsy. Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and/or around the tumor to help target the radiation treatment. Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards. Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET/CT) and blood (PSA) tests. After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.

Eligible Conditions
  • Prostate Cancer
  • Prostate Adenocarcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 2 years

Month 24
Absolute and relative fraction of free PSA to bound PSA
Nadir PSA
PSA kinetics
2 years
Pathologic complete response rate
Month 24
Rate of biochemical failure
Month 24
Toxicity profile
Month 24
Longitudinal quality of life (QoL)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

1/Focal SBRT
1 of 1

Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: 1/Focal SBRT · No Placebo Group · Phase 2

1/Focal SBRTExperimental Group · 2 Interventions: Stereotactic Body Radiation Therapy, 18F-DCFPyL · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~610
18F-DCFPyL
2019
Completed Phase 3
~350

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,085 Previous Clinical Trials
41,141,469 Total Patients Enrolled
536 Trials studying Prostate Cancer
502,352 Patients Enrolled for Prostate Cancer
Krishnan R Patel, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically confirmed, low or intermediate risk prostatic adenocarcinoma.
You have a single focal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted biopsy.
Ability to understand and willingness to sign a written informed consent document.

Who else is applying?

What site did they apply to?
National Institutes of Health Clinical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
What state do they live in?
New York50.0%
California50.0%