| Eligibility |
Inclusion Criteria:
- Age = 18
- Histologically confirmed adenocarcinoma of the prostate gland by needle core samples
with assigned Gleason score
- Subjects ADT naive or subjects who are already on ADT treatment and scheduled to
receive radiation therapy for their adenocarcinoma of prostate are eligible. An 8-week
course of ADT is required to be completed prior to NBTXR3 administration and
initiation of radiation therapy.
- Pelvic and para-aortic lymph nodes must be negative on CT-scan or MRI of the abdomen
and pelvis performed within 12 weeks prior to enrollment into the study
- Prostate adenocarcinoma with High Risk (HR) and Unfavorable Intermediate Risk (UIR)
for recurrence classification as determined by one of the following combinations:
- High risk (HR): subjects with one or more of the following risk factors:
- Clinical stage: T3/T4
- Gleason score (GS): 8-10
- PSA > 20
- N0
- Unfavorable Intermediate Risk (UIR): subjects with no HR features but with one or
more of the following adverse risk factors:
- At least 2 of the following 3 factors: Gleason score(GS) 3+4=7 and/or PSA
10-20 and/or T2b/c
- Gleason score (GS) 4+3=7
- Greater than 50% of biopsy cores positive and at least one other risk
factor:
Gleason score (GS) 7 and/or PSA 10-20 and/or T2b/c
- No evidence of bone metastases (M0) on bone scan within 120 days prior to registration
(PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if bone
CT or MRI of hot spots are negative for metastasis
- Baseline serum PSA value performed with an FDA-approved assay within 120 days prior to
registration. Study entry PSA should not be obtained within 10-day period following
prostate biopsy or following initiation of hormonal therapy
- ECOG performance status must be 0 or 1
- Adequate function of bone marrow:
- Hemoglobin > 100 g/L
- Absolute Neutrophils > 1.5 x 109/L
- Platelets > 100 x 109/L,
- Adequate function of kidney:
- Serum creatinine < 1.5 x ULN
- Adequate function of liver:
- AST = 3.0 x ULN
- ALT = 3.0 x ULN
- Total bilirubin = 1.5 x ULN
- Non-Childbearing Potential: Male subjects and their partners must meet one of the
following criteria to be considered of non-childbearing potential:
- Males have undergone sterilization with appropriately confirmed absence of sperm
in the post-vasectomy ejaculate, or
- Heterosexually active males and their partners of childbearing potential must
agree or use at least 2 forms of highly effective methods of contraception,
including at least 1 barrier method. Highly effective methods of contraception
are those that, alone or in combination, result in a failure rate of <1% per year
when used consistently and correctly (i.e., perfect use). Contraception must
include male condom or female condom used with a spermicide (i.e., foam, gel,
film, cream, suppository) as well as established use of oral, injected or
implanted hormonal methods of contraception, correctly placed intrauterine device
or intrauterine system.
Exclusion Criteria:
- Written Informed Consent not obtained, signed and dated
- History of colorectal surgery, or repeated endoscopic examinations/interventions
related to anorectal diseases or proximal urethral stricture requiring dilatation
- Prostate size volume =90 cc
- Brachytherapy with EBRT in subjects whose prostate volume is >60cc
- Severe, active co-morbidity, defined as follows:
- Inflammatory bowel disease, active rectal diverticulitis, Crohn's disease
affecting the rectum, anal stenosis or ulcerative colitis. (Nonactive
diverticulitis and Crohn's disease not affecting the rectum are allowed)
- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months
- Myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of randomization
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC (Centers for
Disease Control) definition
- Prior invasive malignancy, except non-melanoma skin cancer, carcinoma in-situ of the
bladder or head and neck region, unless disease free for a minimum of 2 years
- Subjects with congenital long QT syndrome or subjects taking Class IA, Class III or
Class IC anti-arrhythmic medications will require a cardiologist's evaluation prior to
eligibility assessment. subjects with cardiovascular diseases can be included as long
as the benefits of androgen deprivation therapy outweigh the potential risk of
cardiovascular events
- Uncontrolled lung disease
- Subjects with any evidence of distant metastases
- subjects with any contraindication to pelvic radiotherapy including, but not limited
to, previous pelvic radiotherapy or brachytherapy
- Presence of bilateral hip replacement prostheses
- Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral
anti-androgen) exceeding 4 months prior to registration
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or
other physician
- Complete initial work up earlier than 12 weeks prior to subject registration
- Subjects unable to comply with scheduled visits, treatment plans, laboratory tests,
and other study procedures
- Subjects participating in another clinical investigation at the time of signature of
the informed consent.
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