Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Cancer
Prostate Disorders
Treatment
N/AClinical Study ID
Ages 18-99 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
Initial cancer diagnosis that fits these specific criteria:
Stages cT1-T3a
Nx or N0
Mx or M0
Eligible initial definitive radiotherapy modalities include:
External beam radiotherapy, with photon or proton beam therapy
Definitive Brachytherapy
Stereotactic Body Radiotherapy
Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases
Candidate for hormonal therapy.
Current ECOG Performance status Scale 0-2 (Appendix D)
Current International Prostate Symptom Score (IPSS) < 20 (Appendix B)
Age >18
The patient must be medically suitable to receive general or spinal anesthesia.
AST, ALT, and alkaline phosphatase < 2 x upper institutional limit within 3 months of registration.
The patient must be able and willing to sign a study-specific written informed consent form before study entry.
Exclusion Criteria
Preregistration radiation-related GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
Treatment to a "whole pelvis" field with initial radiotherapy
Patients with distant metastases (such as to the bone, visceral organs, and lymph nodes other than the pelvic nodes including the common iliac nodes).
Patients receiving any other investigational agents.
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT.
Study Design
Study Description
Connect with a study center
Loyola University Medical Center
Maywood, Illinois 60153
United StatesActive - Recruiting
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