RecruitingPhase 2

Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor

United States42 participantsStarted 2023-10-19

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required). * Unifocal 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. * Age \>=18 years. * ECOG performance status \<=2 (Karnofsky \>60%). * Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study participation and up to 120 days after the last radiation treatment. * Ability of individual to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Participants with NCCN high-risk prostate cancer features (Gleason score \>=8, \>cT2c, or PSA \>= 20 ng/mL). * Participants with prostate biopsies which show \>= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are not an exclusion criterion). * Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned. * Participants who are receiving any other investigational agents. * Participants found to have pelvic or distant metastases on pre-treatment staging studies. * Participants with an AUA-SI/IPSS score \> 18. * Participants who have previously received curative treatment fo…

What they're measuring

Pathologic complete response rate

Timeframe: 2 years

Trial details

NCT IDNCT05616650

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Debbie-Ann N Nathan, R.N.

(301) 451-8968 dnathan@mail.nih.gov