- Evaluate safety and tolerability of the combination of ADT and docetaxel for up to
three months following the last dose of docetaxel.
- High risk prostate cancer defined as extracapsular extension (cT3a) or seminal vesicle
involvement (cT3b) or invasion of adjacent structures (cT4), serum PSA >20 ng/mL or
Gleason score of 8 to 10 and/or regional lymph node or
- Oligometastatic disease defined as disseminated metastases beyond regional lymph nodes
that meet the following criteria:
- No visceral metastases
- Less than four bony metastases.
- Ability to comply with all study procedures and willingness to remain supine for 120
minutes during imaging.
- Patients must be informed of the experimental nature of the study and its potential
risks, and must sign an Institutional Review Board (IRB)-approved written informed
consent form indicating such an understanding.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
- Patients must be considered candidates for prostatectomy as per standard of care.
- Adequate hematologic and renal function as evidenced by the following within 4 weeks
of day 1:
- ANC >1500/mm3
- Hemoglobin (HgB) >10.0 gr/dL independent of transfusion
- Platelets >100,000/mm3
- Creatinine <2.0 mg/dL
- Total bilirubin < Upper Limit of Normal (ULN)
- Estimated life expectancy of ≥ 12 months at screening.
- Throughout the study, patient and his female partner who is of childbearing potential
must use 2 acceptable methods of birth control (1 of which must include a condom as a
barrier method of contraception) from screening through 3 months after last dose of
study drug. Two acceptable methods of birth control thus include the following:
- A condom (barrier method of contraception) AND One of the following is required:
- Established and ongoing use of oral, injected, or implanted hormonal method of
contraception by the female partner
- Placement of an intrauterine device or intrauterine system by the female partner
- Additional barrier method: Contraceptive sponge or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the
- Tubal ligation in the female partner performed at least 6 months before screening
- Vasectomy or other procedure resulting in infertility (eg, bilateral
orchiectomy), performed at least 6 months before screening
- While receiving chemotherapy, the patient must use a condom if having sex with a
- Must agree not to donate sperm from first dose of study drug through 3 months after
the last dose of study drug.
- Prior treatment for prostate cancer, including ADT, orchiectomy, antiandrogens,
ketoconazole, abiraterone acetate or enzalutamide.
- Prior radiation to the prostate.
- Use of other investigational agent for prostate cancer.
- No active secondary malignancy
- Chronic liver disease or abnormal liver function:
- Total bilirubin >ULN (NOTE: in subjects with Gilbert's syndrome, if total
bilirubin is >ULN, measure direct and indirect bilirubin and if direct bilirubin
is within normal range, subject may be eligible) or
- Alanine (ALT) or aspartate (AST) aminotransferase >2.0 x ULN or
- ALT or aspartate AST >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN.
- Peripheral neuropathy grade >1.
- Active cardiac disease defined as active angina, symptomatic congestive heart failure,
or myocardial infarction within the previous 6 months.
- Major surgery within 4 weeks before screening.
- Patients with known psychological or sociological conditions, addictive disorders or
family problems, which would preclude compliance with the protocol.
- Herbal supplements that have been shown to modulate testosterone or androgen signaling
(e.g. Saw Palmetto) are not allowed while on study.
- Subjects may not be enrolled concurrently on other treatment studies. Any concurrent
disease, infection, or comorbid condition that interferes with the ability of the
patient to participate in the trial; places the patient at undue risk; or complicates
the interpretation of the data, in the opinion of the investigator or medical monitor.
- Subjects who will be receiving Ferumoxytol MRI tracer must:
- Not have any known hypersensitivity to Feraheme or any of its components
- Must not have a history of allergic reaction to any intravenous iron product.
- Must not have a known iron overload (based on medical history)