CLINICAL TRIALS

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 


Phase 0.

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


NCT02489357: Pembrolizumab and Cryosurgery in Treating Patients with Newly Diagnosed, Oligo-metastatic Prostate Cancer


Overview:
Traditionally, men with metastatic (wide spread) prostate cancer were treated with hormonal deprivation. This therapy can extend survival but, in most men, the prostate cancer will adapt and the disease will progress. Immunotherapies (which harness the power, specificity, and adaptability of the immune system) carry with them a potential for disease cure even in the advanced state. This study investigates the combination of immune-stimulatory prostate cryosurgery and Pembrolizumab with standard of care androgen deprivation to achieve therapeutic responses in men with newly diagnosed low volume (less than 5 lesions) metastatic prostate cancer.

PI: Ashley E. Ross MD PhD

Contact Name: Ashley E. Ross MD PhD
Phone: 443-287-7225
Email: aross2@jhmi.edu


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


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.


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


Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate


Treatment trial.

Eligibility:
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Male Accepts Healthy Volunteers: No

Overview:
This will be a Phase II study evaluating the effectiveness and toxicity of a regimen of 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens of 2.5 Gy, 2.7 Gy, and 3.0 Gy daily fractions. The total dose is calculated to be iso-effective for late effects to a conventionally fractionated total dose of 81 Gy, which has been shown to be effective and safe in a large prospective Phase II study. If the alpha/beta ratio for prostate is between 1.5-3.0, then this regimen should be at least as effective or more effective for tumor control than 81 Gy given in conventional fractions.

PI: Danny Song, MD

Contact Name: Contact: Shirl DiPasquale, RN
Phone: 410-614-1598
Email: sdipasq1@jhmi.edu


A study of allogeneic human bone marrow derived mesenchymal stem cells in localized prostate cancer


Prevention trial.

Overview:
The obiective of this study is to determine systemically infused allogenic bone-marrow derived mesenchymal stem cells(MSCs) home to sites of prostae cancer in men with localized adenocarcinoma of the prostate who are planning to undergo a prostatectomy. Secondary objective include safety and looking at changes in Sexual Health Inventory for Men (SHIM) and Expanded Prostate CAncer Index Composite (EPIC) surveys post-prostatectomy.


A parmacodynamic pre-surgical study of hedgehog pathway inhibition with LDE225 in men with high-risk localized prostate cancer


Overview:
This trial is designed as a randomized two-arm (LDE225/observation) open-label prospective clinical trial in men with localized high-risk priostate cancer undergoing radical-prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk os systeic disease progression, by comparing pre-surgical core-biopsy pecimens to tumor tissue harvedsted at the time of prostatectomy.

PI: Emmanuel Antonarakis


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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