Status:
COMPLETED
Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 sometime...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03253744
Start Date
July 5 2018
End Date
January 30 2025
Last Update
October 8 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892