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The Cancer Institute of New Jersey's Clinical Trials Connection, March 2013
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Mark Stein, MD
Mark N. Stein, MD,
is a medical oncologist specializing in prostate cancer and a member of the Phase I Investigational Therapeutics team at The Cancer Institute of New Jersey.

Contact Dr. Stein: 732-235-5773
Clinical Trial Spotlight
Targeted Genomic Analysis of Human Cancers
The purpose of this study is to identify potentially 'actionable' genomic alterations in cancers using next-generation sequencing technology, with a focus on rare cancers and cancers for which there is limited standard therapy. 


Other Available Trials


Prostate Cancer Clinical Trials
NCI/CTEP #7354: Ph II trial with Prostvac/TRICOM and flutamide vs flutamide in D0.5 prostate cancer

The study aims to:
  • Determine if use of a combination of vaccine plus flutamide may be associated with a trend toward improvement in time to treatment failure compared to flutamide alone.   
  • Determine preliminary evidence of any patterns of immunologic effects which differ by treatment including the immunologic effects of flutamide withdrawal on patients continuing on vaccine following a rising PSA on flutamide.

Learn more about this trial

ECOG 2809: Phase II MK-2206 - Bicalutamide Combination in Patients With Rising PSA

The study aims to:
  • Compare the two regimens on the proportion of patients with undetectable PSA level (< 0.2 ng/mL) at 44 weeks.    
  • Assess the proportion of patients with PSA decline > 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm. failure compared to flutamide alone.  

Learn more about this trial

JHU: Efficacy and Safety of Oral Kanglaite (KLTc) Gelcap in Men with Prostate Cancer

The study aims to:
  • Evaluate the effects and safety of two different doses (3 or 6 capsules, four times daily) of KLTc on prostate specific antigen doubling time (PSADT) in men who have rising PSA after initial local therapy for localized prostate cancer during 12 months of study period. 
  • Assess the safety and toxicity of two daily dose regimens of KLTc. To compare the effect on PSADT between two dose groups. 

Learn more about this trial

Stereotactic Hypofractionated Accelerated Radiation and Prostatectomy
(The SHARPER Trial - Phase I)

The study aims to:
  • A phase 1 non-randomized, single arm, prospective study of pre-operative stereotactic body radiotherapy (SBRT) followed by prostatectomy in high risk prostate cancer patients. 
  • Assess genitourinary and gastrointestinal toxicities at 1, 3, 6 and 12 month intervals after surgery. Toxicities should be graded according to Common Terminology Criteria for Adverse Events (CTCAE, v3.0) with acute toxicity at 1 month follow-up and late toxicity at greater than one month follow-up. 

Learn more about this trial

Phase III Cabozantinib (XL184) vs. Mitoxantrone Plus Prednisone in
Prostate Cancer

The study aims to:
  • Evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone. Efficacy will be measured by (1) proportion of subjects with pain response at week 6 confirmed at week 12. (2) Bone scan response at week 12 per IRF (primary analysis designates subjects with soft tissue progression as non-responders). (3) Overall survival. 

Learn more about this trial

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, The Cancer Institute of New Jersey offers patients access to treatment options not available at other institutions within the state. The Cancer Institute of New Jersey currently enrolls more than 3,500 patients in clinical trials annually, including approximately 17 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in these studies nationwide is fewer than five percent of all adult cancer patients. Learn more