NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

BIOLEN-PC: A Study to Establish the Feasibility of Biolen (R) for the Local Delivery of Bicalutamide in Patients with Prostate Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 35 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Lower Urinary Tract Symptoms;
Urological Manifestations;
Androgen Antagonists;
Hormone Antagonists;
Hormones, Hormone Substitutes, And Hormone Antagonists;
Physiological Effects of Drugs;
Antineoplastic Agents

Recruitment Keyword(s)



Prostate Adenocarcinoma;
Lower Urinary Tract Symptoms

Investigational Drug(s)


Investigational Device(s)



Drug: Biolen

Supporting Site

National Cancer Institute


Prostate cancer is the second most frequent cancer diagnosis in men and the fifth leading cause of death worldwide. Current treatments, such as prostate removal or radiation, can have a negative impact on quality of life. Better treatments are needed.


To test an implanted device (Biolen) that will deliver a drug (bicalutamide or Casodex (Registered Trademark)) directly into the prostate in people with prostate cancer.


People aged 35 years and older with prostate cancer who plan to have their prostate removed.


Participants will have 7 or 8 visits with the study doctor.

Participants will be screened. They will have a physical exam and blood and urine tests. They will complete two surveys about their prostate health. They may have an MRI.

The Biolen device will be implanted approximately 12 weeks before the scheduled prostate removal. The procedure will be done in a hospital with the participant under sedation or general anesthesia. Some participants may need to stay overnight.

Participants will meet with the study doctor 1 day and 1, 4, 8, and 12 weeks after the implant procedure. They will answer questions about how they are feeling and any symptoms they may have. They will be asked about any changes in their medications. Blood will be drawn for testing at each visit. The visit at 12 weeks will include an MRI.

The device will be removed during the participant s scheduled prostate surgery.

The last study visit will be 2 to 4 weeks after the surgery. Participants will have blood drawn. They will complete questionnaires about their prostate health.

--Back to Top--



Study participants must meet all the following inclusion criteria to be eligible for study participation:

-Age at least 35 years old.

-Histologically confirmed adenocarcinoma of the prostate.

-Study participant qualified and planning for radical prostatectomy.

-At least 1 prostate lesion measurable by MRI > 0.5 cm.

-PSA > 3 ng/mL within 3 months of screening.

-Gleason score 3+4 or higher.

-Study participant must be willing to undergo post-treatment imaging by MRI.

-Participants must be able to understand and sign the informed consent form.

-ECOG performance status 0 or 1.

-Adequate organ function, including absolute neutrophil count (ANC) >= 1500 cells/microL, hemoglobin >= 90 g/dL, platelets >= 100,000 cells/microL, estimated creatinine clearance >= 50 mL/min, bilirubin <1.5X ULN (< 3X ULN for documented Gilbert s syndrome).

-Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase <2.5X ULN.

-The effects of Biolen 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:


--Condom with spermicide

--Partner use of one of the following methods:


---Bilateral tubal ligation

---Intrauterine devices (IUDs)

---Hormonal implants (Implanon)

---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.


Study participants must meet none of following exclusion criteria to be eligible for study participation:

-Prior radiotherapy or surgery for prostate cancer.

-Prior or ongoing hormonal therapy for prostate cancer.

-Prior prostate procedures local to the implant location(s), such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure.

-Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.

-Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.

-Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.

-Use of 5 alpha reductase inhibitors (e.g., Finasteride or Dutasteride) within 3 months of screening.

-Presence of any metastatic disease.

-Prostate volume more than 80 cc at prior MRI imaging.

-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 Biolen implant.

-History of prostate infection.

-No intercurrent medical condition or circumstances that would preclude prostatectomy.

-History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.

-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.

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Peter A. Pinto, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5952
(240) 858-3700

Michele L. Reed (Diffenderfer), R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2L324A
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6121

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


--Back to Top--