This study is currently recruiting participants.
Number
001837-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male Min Age: 21 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Enzalutamide
Recruitment Keyword(s)
Condition(s)
Adenocarcinoma; Prostate Cancer; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type
Investigational Drug(s)
Enolen Implantable Depot-Enzalutamide
Investigational Device(s)
Intervention(s)
Drug: Enzalutamide
Supporting Site
National Cancer Institute
At baseline, patients will undergo multiparametric MRI of the prostate. Study participants will have placement of the drug eluting Enolen implants. Six to twelve weeks later, the patient will undergo a repeat MRI followed by standard of care radical prostatectomy.
Participants will be followed for an additional 6-12 weeks post surgery. Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits.
--Back to Top--
INCLUSION CRITERIA: Study participants must meet all the following inclusion criteria to be eligible for study participation: 1. Age at least 21 years old 2. Histologically confirmed adenocarcinoma of the prostate 3. Study participant qualified and planning for radical prostatectomy 4. At least 1 prostate lesion measurable by MRI >= 0.5 cm 5. PSA >= 3 ng/mL within 3 months of screening 6. Gleason score 3+4 or higher 7. Study participant must be willing to undergo post-treatment imaging by MRI 8. Participants must be able to understand and sign the informed consent form 9. ECOG performance status 0 or 1 10. Adequate organ function, including absolute neutrophil count (ANC) >=1000 cells/microL, hemoglobin >=90 g/dL, platelets >=100,000 cells/microL, estimated creatinine clearance >=50 mL/min, bilirubin <1.5 x ULN (< 3 x ULN for documented Gilbert s syndrome). 11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase <2.5 x ULN 12. The effects of Enolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and continuing through three months after radical prostatectomy/implant removal. Highly effective forms of contraception include: -Vasectomy -Condom with spermicide -Partner use of one of the following methods: --Postmenopausal >1 year or age >55y --Bilateral tubal ligation --Intrauterine devices (IUDs) --Hormonal implants (Implanon, Nexplanon, etc.) --Combination oral contraceptives --Progestin-only oral contraceptives that inhibit ovulation --Progestin-only injections (Depo-Provera) --Hormonal patches --Vaginal Ring Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately. EXCLUSION CRITERIA: Study participants must meet none of following exclusion criteria to be eligible for study participation: 1. Prior radiotherapy or surgery for prostate cancer 2. Ongoing hormonal therapy for prostate cancer or hormone therapy <3 months prior to the start of treatment 3. Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure 4. Study participant unwilling or unable to undergo MRI, including participants with contraindications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc. 5. Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images 6. Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent 7. Use of 5 alpha reductase inhibitors (e.g., Finasteride or Dutasteride) within 3 months of screening 8. Presence of any metastatic disease 9. No evidence of extracapsular extension of disease 10. Study participants, who in the opinion of the treating clinician, would be at increased risk of refractory urinary retention due to a transperineal procedure such as the Enolen implant 11. History of prostate infection within 2 years 12. No intercurrent medical condition or circumstances that would preclude prostatectomy 13. History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure 14. Any condition that, in the opinion of the Principal Investigator, which would impair the participant s ability to comply with study procedures and undergo prostatectomy
Study participants must meet all the following inclusion criteria to be eligible for study participation:
1. Age at least 21 years old
2. Histologically confirmed adenocarcinoma of the prostate
3. Study participant qualified and planning for radical prostatectomy
4. At least 1 prostate lesion measurable by MRI >= 0.5 cm
5. PSA >= 3 ng/mL within 3 months of screening
6. Gleason score 3+4 or higher
7. Study participant must be willing to undergo post-treatment imaging by MRI
8. Participants must be able to understand and sign the informed consent form
9. ECOG performance status 0 or 1
10. Adequate organ function, including absolute neutrophil count (ANC) >=1000 cells/microL, hemoglobin >=90 g/dL, platelets >=100,000 cells/microL, estimated creatinine clearance >=50 mL/min, bilirubin <1.5 x ULN (< 3 x ULN for documented Gilbert s syndrome).
11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase <2.5 x ULN
12. The effects of Enolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and continuing through three months after radical prostatectomy/implant removal.
Highly effective forms of contraception include:
-Vasectomy
-Condom with spermicide
-Partner use of one of the following methods:
--Postmenopausal >1 year or age >55y
--Bilateral tubal ligation
--Intrauterine devices (IUDs)
--Hormonal implants (Implanon, Nexplanon, etc.)
--Combination oral contraceptives
--Progestin-only oral contraceptives that inhibit ovulation
--Progestin-only injections (Depo-Provera)
--Hormonal patches
--Vaginal Ring
Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately.
EXCLUSION CRITERIA:
Study participants must meet none of following exclusion criteria to be eligible for study participation:
1. Prior radiotherapy or surgery for prostate cancer
2. Ongoing hormonal therapy for prostate cancer or hormone therapy <3 months prior to the start of treatment
3. Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure
4. Study participant unwilling or unable to undergo MRI, including participants with contraindications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
5. Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images
6. Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent
7. Use of 5 alpha reductase inhibitors (e.g., Finasteride or Dutasteride) within 3 months of screening
8. Presence of any metastatic disease
9. No evidence of extracapsular extension of disease
10. Study participants, who in the opinion of the treating clinician, would be at increased risk of refractory urinary retention due to a transperineal procedure such as the Enolen implant
11. History of prostate infection within 2 years
12. No intercurrent medical condition or circumstances that would preclude prostatectomy
13. History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure
14. Any condition that, in the opinion of the Principal Investigator, which would impair the participant s ability to comply with study procedures and undergo prostatectomy
Principal Investigator
Referral Contact
For more information: