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

NCT05616650 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10000611000611-C
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostatic Neoplasms

Keywords

Sbrt; PSMA; Targeted Pet Imaging; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response rate

  The primary objective of this trial is to determine the pathologic complete response rate on biopsy at two years in patients undergoing focal SBRT for prostate cancer. This will be defined by a negative biopsy at 2 years post-treatment.

  2 years

Secondary Outcomes (6)

• Longitudinal quality of life (QoL)

  baseline and 1, 3, 6, 9, 12, 15, 18, 21, and 24 months after focal SBRT

• PSA kinetics

  1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT

• Nadir PSA

  1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT

• Absolute and relative fraction of free PSA to bound PSA

  1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT

• Toxicity profile

  During the focal SBRT period and 1, 3, 6, 9, 12, 18, 24 months after focal SBRT

Study Arms (1)

1/Focal SBRT

EXPERIMENTAL

Focal SBRT to the tumor focus within the prostate, with response assessed by biopsy and imaging, including 18F-DCFPyL PET/CT.

Drug: 18F-DCFPyL; Radiation: Stereotactic Body Radiation Therapy

Interventions

18F-DCFPyL DRUG

Each participant will receive a single IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi; dose variations will be in accordance with the Nuclear Regulatory Commission (NRC) standard dose variation (i.e., 20%) permitted for diagnostic clinical studies.

1/Focal SBRT

Stereotactic Body Radiation Therapy RADIATION

Intensity modulated radiotherapy will be delivered to a dose of 26Gy in two fractions with the second fraction performed within 8 days of the first session.

1/Focal SBRT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants with NCCN high-risk prostate cancer features (Gleason score \>=8, \>cT2c, or PSA \>= 20 ng/mL).
• 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 for a prior or the current diagnosis of prostate cancer.
• Active urinary tract infection assessed by urinalysis.
• Human immunodeficiency virus (HIV)-infected individuals who are not on effective anti-retroviral therapy. Participants on anti-retroviral therapy with undetectable viral load within the 6 months prior to registration are eligible for this trial.
• Participants with hepatitis B virus (HBV) infection who have not been treated and cured.
• Participants with chronic HBV at screening must have an undetectable HBV viral load on suppressive therapy.
• Participants with hepatitis C virus (HCV) infection who have not been treated and cured.
• Participants with HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.
• Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.
• Participants with connective tissue diseases.
• Participants with radiation hypersensitivity syndromes.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Deborah E Citrin, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debbie-Ann N Nathan, R.N.

CONTACT

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

Deborah E Citrin, M.D.

CONTACT

(240) 760-6206; citrind@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 15, 2022
• Study Start: October 19, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04-13

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint.@@@@@@If dbGaP is applicable: Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Data from this study may be requested by contacting the PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)