Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

NCT ID: NCT03253744

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2025-01-30

Brief Summary

Background:

Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).

Objective:

To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation.

Eligibility:

Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease.

Design:

Participants will be screened with blood tests, physical exam, and medical history. They may also have:

Magnetic resonance imaging (MRI) scan of the prostate.

Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an injection of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) for the PET scan. They will lie very still on their back on the scanner table.

Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation.

About 2 weeks later, participants will have a radiation treatment planning CT scan.

Participants will answer questions about their urine function, bowel function, erectile function, and mood.

Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.

Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires.

Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated.

Participants will continue to have routine visits until two years after treatment is completed....

Detailed Description

Background:

• Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to the side effects of available treatments such as surgery and cryoablation.
• Re-irradiation with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer disease control with tolerable side effects.
• Using image guidance to allow highly conformal focal re-irradiation may potentially increase the efficacy of re-irradiation.

Objectives:

-Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence of prostate cancer after prior radiotherapy.

Eligibility:

• Histological confirmation of recurrent prostate cancer after prior irradiation (external beam or brachytherapy)
• No evidence of distant metastases of prostate cancer
• No prior prostatectomy
• Subject is greater than or equal to18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).

Design:

• This is a Phase I trial of focal dose escalation with SBRT using image and pathologic guidance.
• Areas in the prostate shown to have tumor on biopsy or with advanced imaging studies will be treated with highly conformal SBRT over a period of two to three weeks. Treatment will be guided and gated by fiducials implanted in the prostate.
• Patients will be treated to escalating doses based on tolerability of the treatment.
• Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires.
• Up to 52 patients will be enrolled.

Conditions

Prostate Cancer; Prostatic Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1, Level 1, Arm 1: Tumor Irradiation

Arm 1: Tumor irradiation.

Cohort 1, Level 1, Arm 1 - 40 gray (Gy) to Tumor planning target volume (PTV)

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.

External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: DRUG

Participants will receive 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.

Tumor Irradiation

Intervention Type: RADIATION

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.

Tumor Irradiation

Intervention Type: RADIATION

External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Cohort 1, Level 2, Arm 1 - Tumor Irradiation

Arm 1: Tumor irradiation.

Cohort 1, Level 2, Arm 1 - 42.5 gray (Gy) to Tumor planning target volume (PTV)

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.

External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: DRUG

Participants will receive 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.

Tumor Irradiation

Intervention Type: RADIATION

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.

Tumor Irradiation

Intervention Type: RADIATION

External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation

Arm 2: Prostate and tumor irradiation

Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV)

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.

Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: DRUG

Participants will receive 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.

Prostate + tumor irradiation

Intervention Type: RADIATION

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.

Tumor Irradiation

Intervention Type: RADIATION

External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation

Arm 2: Prostate and tumor irradiation

Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.

Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.

Group Type: EXPERIMENTAL

18F-DCFPyL

Intervention Type: DRUG

Participants will receive 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.

Prostate + tumor irradiation

Intervention Type: RADIATION

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.

Tumor Irradiation

Intervention Type: RADIATION

External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Interventions

18F-DCFPyL

Participants will receive 2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.

Intervention Type: DRUG

Tumor Irradiation

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.

Intervention Type: RADIATION

Prostate + tumor irradiation

Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.

Intervention Type: RADIATION

Tumor Irradiation

External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.

Intervention Type: RADIATION

Other Intervention Names

2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid; SBRT; SBRT; EBRT

Eligibility Criteria

Inclusion Criteria

• Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (external beam radiation therapy (EBRT) or brachytherapy).
• Prostate-specific antigen (PSA) failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 nanograms (ng) per deciliter (dL) above post-radiotherapy nadir)
• Age greater than or equal to 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
• Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Patients who are receiving any other investigational agents.
• PSA greater than or equal to 20 ng/dL if no prior 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) scan obtained (If PSA > 20 and 18F-DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study)
• Biochemical recurrence within one year of completion of radiotherapy
• Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
• Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
• Inflammatory bowel disease
• Active Lupus or Active scleroderma
• Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion)
• Prior prostatectomy
• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
• Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
• Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures
• Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
• Serum creatinine > 2 times the upper limit of normal
• Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin > 3.0.
• Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 3 times the upper limit of normal
• Patients with positive Human Immunodeficiency Virus (HIV) status and currently requiring treatment with agents known to sensitize to irradiation, such as protease inhibitors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Deborah Citrin, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah E Citrin, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-C-0153.html

NIH Clinical Center Detailed Web Page

Other Identifiers

17-C-0153

Identifier Type: -

Identifier Source: secondary_id

170153

Identifier Type: -

Identifier Source: org_study_id