Prostate Cancer Clinical Trial

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Summary

Background:

Prostate cancer is the second leading cause of cancer death in 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..

PET/CT scan. Participants will get an injection of 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.

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

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT03253744

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT03253744

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.