CLINICAL TRIALS

Neoadjuvant enoblituzumab (MGA271) in men with localized intermediate and high-risk prostate cancer – a pilot and biomarker study


Eligibility:
  1. Male, 18 years of age and older, with prostate cancer, Gleason 4+3=7 or higher, with at least 2 positive cores
  2. Clinical stage T1c-T3b, no lymph node or bone or visceral organ involvement
  3. Adequate lab values (bone marrow, hepatic, renal function)
  4. Willingness to use barrier contraception from the time of first dose of MGA271 until time of prostatectomy
  5. No prior radiation/hormonal/biologic/chemo- therapy treatment(s) for prostate cancer
  6. No systemic corticosteroids and no autoimmune disease requiring immunosuppression
  7. No malignancy within last 3 years (except non-melanoma skin cancers and superficial bladder cancer)
  8. No uncontrolled major active condition and no known history of HIV and/or hepatitis B/C


Overview:
This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant MGA271 given prior to radical prostatectomy in men with intermediate and high-risk localized prostate cancer. Eligible patients will receive MGA271 at a dose of 15mg/kg IV given weekly for 6 doses beginning 50 days prior to radical prostatectomy at JHH; 14 days after the last dose of MGA271, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined.. Follow-up evaluation for adverse events will occur 30 days and 90 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.

PI: Dr. Emmanuel Antonarakis

Contact Name: Carolyn Chapman, BA, RN
Phone: (443) 287-7841
Email: cchapma7@jhmi.edu


Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)


Eligibility:
Ages Eligible for Study: 50 Years and older (Adult, Senior)
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Must be male to screen for prostate cancer
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample

Study Population
Male, 50+ years of age with a clinical suspicion for prostate cancer based in part on an elevated Prostate-specific antigen (limit range: 2.0 - 10 ng/ mL), and or suspicious DRE, without the clinical history of a prior negative biopsy.

Criteria

Inclusion Criteria:
•50 years of age
•Clinical suspicion for prostate cancer
•Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
•No clinical history of a prior negative biopsy

Exclusion Criteria:
•History of prior prostate biopsy.
•Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
•Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
•History of prostate cancer.
•History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
•No known hepatitis (all types) and/or HIV documented in patient's medical record.
•Patients with history of concurrent renal/bladder tumors.


Overview:
The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).

Contact Name: Elizabeth Fabian
Phone: (410) 614-9261
Email: efabian2@jhmi.edu


PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (PREVENTER)


Eligibility:
Ages Eligible for Study: 18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
•Men 18-100 years of age with histologically confirmed prostate cancer of any stage undergoing RP
•Patients who would have otherwise been eligible to receive routine post-RP care

Exclusion Criteria:
•Active treatment for VTE
•Patients judged by their urologist, primary care doctor, or in the preoperative evaluation center (PEC) to be unsafe to forgo pharmacologic prophylaxis or systemic anticoagulation postoperatively (whether or not they are on systematic anticoagulation for indications other than VTE)
•Known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy)
•Epidural analgesia
•Spinal anesthesia
•Participation in a different trial that increases a patient's risk of VTE

Overview:
The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP).

PI: Hiten D Patel, MD, MPH - Mohamad E Allaf, MD

Contact Name: Hiten D Patel, MD, MPH
Phone: 410-502-7710
Email: hitenpatel@jhmi.edu


Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy


Eligibility:
Ages Eligible for Study: 40 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
•Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7, 3+2=5, 2+3=5, cT1c, cT2a, cT2b, preoperative prostatic specific antigen (PSA) less than 10)
•between ages 40-70
•preoperative IIEF (erectile function domain) score equal or greater than 20
•IPSS less than 10 and no urinary incontinence

Exclusion Criteria:
•Men with neurological disease
•IIEF score less than 20
•high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA > 10)
•spinal cord injury
•history of transurethral resection of prostate (TURP) or other prostate ablative procedures
•history of priapism, pelvic neuropathy, penile skin lesions/ulcers
•inability to understand and demonstrate device use instructions.


Overview:
The purpose of this study is to evaluate whether using penile vibratory stimulation with the Viberect handheld device can help the recovery of erections and urinary control after radical prostatectomy.

PI: Arthur L Burnett, MD, MBA

Contact Name: Angela Koomson
Phone: 410-502-6407
Email: akoomso1@jhmi.edu


ClariCore™ Biopsy System in Patients Undergoing Radical Retropubic Prostatectomy


Eligibility:
Ages Eligible for Study: 18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
• Patient scheduled for radical retropubic prostatectomy
• Prostate volume > 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or MRI
• Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

Exclusion Criteria:
• Patient opted for robotic (da Vinci robot) or laparoscopic surgery
• Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
• Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
• Bladder cancer (current or prior)
• Actively taking blood thinning agents (with the exception of low dose aspirin {81 mg}, Plavix, Coumadin etc.) or severe medical comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g. coagulopathy)
• Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years
• Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostate) • Neo-adjuvant hormonal therapy
• Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
• Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
• Patient is not likely to comply with the follow-up evaluation schedule
• Patient is participating in a clinical trial of another investigational drug or device
• Patient is mentally incompetent or a prisoner


Overview:
The purpose of the study is to collect information on prostate tissue biopsies collected with the ClariCore System during a radical prostatectomy procedure. The ClariCore System is designed to improve how biopsies are taken from the prostate by using light sensors (fiber optics) that can see changes in the tissue. The information collected from the study will be used to develop a method to tell the difference between normal and suspicious tissue to help guide the physician during a biopsy procedure.

PI: Alan W Partin

Contact Name: Robin Gurganus, RN, CCRC
Phone: 410-614-6926
Email: rgurganus@jhmi.edu


A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy


Eligibility:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:
1. Willing and able to provide written informed consent.
2. Age ≥ 18 years
3. Eastern cooperative group (ECOG) performance status ≤2
4. Documented histologically confirmed adenocarcinoma of the prostate
5. Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. Additionally, must be willing to be treated with a full two years of androgen deprivation.
6. Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or PET scan)

Exclusion Criteria:
1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy, brachytherapy)
2. Prior therapy to a metastatic site.
3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
    1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
    2. CYP-17 inhibitors (e.g. ketoconazole)
    3. Antiandrogens (e.g. bicalutamide, nilutamide)
    4. Second generation antiandrogens (e.g. enzalutamide, abiraterone)
    5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)
    6. Chemotherapy (e.g. docetaxel, cabazitaxel) *Note: may be enrolled if hormone therapy was recently initiated (<90 days duration)). In the event that hormone therapy was initiated prior to study enrollment, the clock for 2 years of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment.
4. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
5. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
6. Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]
7. Abnormal liver function (bilirubin >ULN; AST, ALT > 2.5 x upper limit of normal)
8. Creatinine clearance of ≥ 30 mL/min. CrCl should be calculated suing the Cockcroft-Gault formula.
9. Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.
10.Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.

Overview:
To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

PI: Kenneth Pienta

Contact Name: Rana Sullivan
Phone: 410-614-6337
Email: tomalra@jhmi.edu


A Study of Definitive Therapy to Treat Prostate Cancer (oligo-mets)


Eligibility:
Ages Eligible for Study: 18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
1.Willing and able to provide written informed consent.
2.Age ≥ 18 years
3.Eastern cooperative group (ECOG) performance status ≤2
4.Documented histologically confirmed adenocarcinoma of the prostate
5.Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. Additionally, must be willing to be treated with a full year of androgen deprivation.
6.Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or PET scan)
7.Able to swallow the study drugs whole as tablets

Exclusion Criteria:
1.Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
2.Prior therapy to a metastatic site.
3.Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
    1.Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
    2.CYP-17 inhibitors (e.g. ketoconazole)
    3.Antiandrogens (e.g. bicalutamide, nilutamide)
    4.Second generation antiandrogens (e.g. enzalutamide, abiraterone)
    5.Immunotherapy (e.g. sipuleucel-T, ipilimumab)
    6.Chemotherapy (e.g. docetaxel, cabazitaxel) *Note: may be enrolled if hormone therapy was recently initiated (<90 days duration)). In the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment.
4.Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
5.Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
6.Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]
7.Abnormal liver function (bilirubin >ULN; AST, ALT > 2.5 x upper limit of normal)
8.Creatinine clearance of ≥ 30 mL/min. CrCl should be calculated suing the Cockcroft-Gault formula.
9.Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.
10.Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.


Overview:
To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

PI: Kenneth Pienta

Contact Name: Carolyn Chapman
Phone: 443-287-7841
Email: cchapma7@jhmi.edu


Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy (ERECT)


Eligibility:
Ages Eligible for Study: 40 Years to 65 Years (Adult) Sexes Eligible for Study: Male Accepts Healthy Volunteers: No Criteria Inclusion Criteria: •Patient eligibility consists of men 40 to 65 years of age •Localized prostate cancer ◦clinical stage T2a or lower ◦Gleason grade of 3+4 or 3+3 ◦prostate specific antigen (PSA) < 10 •Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function •International Index of Erectile Function-5 [IIEF-5] score of 22-25. •The patient has a sexual partner, of at least 6 months. •The patient's pre-surgical hematocrit is ≤ 48. •The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery. Exclusion Criteria: •The patient has known penile deformity or a history of Peyronie's disease. •The patient has planned pre or post operative androgen therapy. •The patient has planned pre or post operative radiation therapy. •The patient is on anticoagulation therapy. •The patient has a history of sickle cell anemia. •The patient has a history of high or low blood pressure that is not controlled. •The patient is taking medications called "nitrates" •The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction •The patient has a history of history of drug or alcohol abuse. •The patient currently smokes or has a 20 pack/year history of cigarette smoking. •The patient has a history of acute or chronic depression •The patient has a history liver problems, or kidney problems. •The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy. •The patient has a history of spinal trauma or surgery to the brain or spinal cord. •The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors. •Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.

Overview:
This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer. Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function. Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery.

PI: Mohamad E Allaf

Contact Name: Mohamad E Allaf
Phone: 410-502-7710
Email: mallaf@jhmi.edu


Transrectal Ultrasound Robot-Assisted Prostate Biopsy


Eligibility:
Ages Eligible for Study: 40 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
•Scheduled for an initial diagnostic biopsy
•Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam

Exclusion Criteria:
•Clinical diagnosis of prostate cancer
•Prior prostate biopsy
•Anal stenosis that prevents TRUS probe insertion
•Inadequate bowel prep
•Unwilling or unable to sign the informed consent


Overview:
The commonly used diagnostic procedure for prostate cancer, a transrectal ultrasound (TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are poorly targeted and their spatial mapping remains subjective.

1.Number of patients with treatment-related adverse events [ Time Frame: 1.5 years ] The PI will contact each participant approximately one week after their biopsy to ask if they have experienced any adverse events due to the study device. If all 5 participants complete the procedure and fail to report any adverse events, the device will be considered safe for use during biopsy.

2.Number of patients for whom the study-related procedures can be completed in less than 30 minutes [ Time Frame: 1.5 years ] The amount of time to complete the study-related portion of the biopsy will be noted. If the study-study portion of the biopsy is able to be completed in less than 30 minutes for each of the 5 participants, then the device will be considered feasible for use during biopsy.

PI: Misop Han

Contact Name: Vince Torres
Phone: 410-502-5938
Email: vtorres7@jhmi.edu


Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer


Eligibility:
Ages Eligible for Study: 18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population
Adenocarcinoma of the prostate

Criteria

Inclusion Criteria:
1.Age ≥18 years
2.Willingness to signed informed consent
3.Histologically confirmed adenocarcinoma of the prostate
4.PSA measurement ≤60 days prior to study enrollment
5.Completed radiographic evaluation with whole-body bone scan (99mTc-MDP or Na18F) and cross-sectional imaging (CT or MRI) of the abdomen and pelvis ≤60 days prior to study enrollment

Exclusion Criteria:
1.Administered a radioisotope within 5 physical half-lives prior to study enrollment
2.History of other malignancy diagnosed within the last 5 years (exceptions: low grade urothelial carcinoma of the bladder, squamous cell carcinoma or basal cell carcinoma of the skin).


Overview:
In this study we aim to more precisely define the clinical utility of PSMA imaging across a range of clinical indications in men with prostate cancer. To accomplish this, we will make the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation oncologists at Johns Hopkins and survey physicians as to the indication for ordering the PET/CT and if a change in management occurred as the result of new information gained from the scan. We believe these data will prove critical for planning future studies aimed at evaluating the efficacy of this test for improving patient outcomes.

PI: Kenneth Pienta

Contact Name: Michael Gorin, MD
Phone: 410-955-6070
Email: mgorin1@jhmi.edu


Phase II Randomized, Placebo-Controlled Trial of PROSTVAC (PSA-TRICOM) in Patients with Clinically Localized Prostate Cancer Undergoing Active Surveillance (DCP Protocol #: UAZ2014-03-01)


Phase II.

Eligibility:
People with prostate cancer who are followed by active surveillance may join. Inclusion criteria include: Biopsy-proven adenocarcinoma of the prostate with less than equal to 50% of the cores positive for cancer, clinical stage less than equal to T2a, Gleason score less than equal to (3+4) equal to 7; confirm availability of pre-study biopy tumore tissue; screening serum PSA less than 15 ng/mL. Exclusion criteria include: no prior treatment for prostate cancer by surgery, irradiation, local ablative, or androgen-deprivation therapy; no distant metastases; no immunodeficiency.

Overview:
This study has two study groups. Group 1 will receive the study vaccine PROSTVAC and Group 2 will receive a placebo by random assignment. Two-thirds of the participants will be placed in Group 1 and one-third in Group 2 within 90 days and once you are determined to be eligible after the Screening Visit, an injection of the priming vaccine or placebo will be given at the Baseline Visit. You will need to avoid close contact with the following individuals for 3 weeks after the priming injection: children less than equal to 3 years of age, immunocompromised individuals, individuals with skin disorders, and pregnant or breast feeding women. During the study, you will return to the clinic at 2, 4, 8, 12, 16, and 20 weeks after the Baseline Visit for booster vaccine or placebo. There is no risk of infecting immunocompromised individuals with the booster vaccines so no contact restriction. Post Intervention Visit will take place 1-2 weeks after the last vaccine, including the post-intervention prostate biopsy as part of your routine care.

PI: Dr. Christian Pavlovich

Contact Name: Lucinda Robinson, RN
Phone: 410 550-9589

TULSA-PRO therapy for MRI-guided minimally-invasive whole gland ablation of low and low-intermediate risk prostate cancer 


Eligibility:
An international multi-institutional trial of a new minimally-invasive transurethral ultrasound technology for prostate ablation, open to men with previously untreated low to low-intermediate grade prostate cancer. Some of the eligibility criteria:  
 
1. Male, age 45 to 80 years 
2. Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before study (or at the discretion of PI and approval by the Sponsor) 
3. Clinical stage ≤ T2b 
4. Gleason score ≤ 3 + 4 
5. PSA ≤ 15 ng/ml 
6. Eligible for MRI 
7. Eligible for general anesthesia 
8. Prostate volume ≤ 90 cc on baseline MRI

Overview:
The Johns Hopkins School of Medicine is happy to announce the opening of this new pivotal trial for the use of Transurethral Ultrasound Prostate Ablation (TULSA) for the treatment of localized low and low-intermediate risk prostate cancer.  The TULSA-Pro device is being studied as a minimally-invasive, MRI-guided approach to treat prostate cancer.  If you are interested, you can read more about the trial either on our national clinical trials registration site (https://clinicaltrials.gov/ct2/show/NCT02766543) or by visiting http://www.profoundmedical.com/

PI: Dr. Pavlovich

Contact Name: Carolyn Chapman, BA, RN
Phone: (443) 287-7841
Email: cchapma7@jhmi.edu


PSMA Imaging with 18F-DCFPyL PET/CT To Allow for Improved Identification of Prostate Cancer After Surgery


Phase 0.

Overview:
18F-DCFPyL is a novel low-molecular weight PET imaging agent which was developed to target prostate cancer cells which overexpress a protein known as PSMA (prostate specific membrane antigen). In an attempt to aid clinicians in managing patients with a PSA-only recurrence after radical prostatectomy we are investigating the accuracy of 18F-DCFPyL PET/CT in this clinical context. With this information, physicians have been able to customize treatment plans for these patients.

PI: Kenneth Pienta, MD

Contact Name: Narineh Abrahamian
Phone: 443-287-7790
Email: nabrah10@jhmi.edu


Supplementation Trial of Vitamin E in Prostate Cancer Patients (STEP)


Overview:
Patients will be randomly assigned to take Vitamin E or placebo to determine if Vitamin E can change biological markers that may be important in causing prostate cancer.

PI: Drs. H. Ballentine Carter & HanYao Huang


J1408 A phase 2 Study of Bicalutamide Plus Finasteride in Men with MRI Detectable Prostate Nodules Undergoing Active Surveillance


Prevention trial.

Overview:
The primary objective of this study are to determine the negative re-biopsy rate as determined by MRI/TRUS-fusion guided biopsy targeting the dominant nodule site defined by pre-treatment MRI following 90 days of combination bicalutamide plus finasteride. Secondary endpoints include rate of exit from active surveillance at two years, safety, and quality of life.

PI: Ken Pienta


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