MDACC Study Summary 2008-0069

Study Summary
No. 2008-0069:.......Prostate......Amado Zurita......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2008-0069

Study Title:	Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

Physician

New Patient Referral



Name:	Amado Zurita	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	Pfizer

Phase of Study:	N/A	Return Visit:	Patients will return to the clinic every 2 weeks for the first 4 weeks, then will have surgery between Days 36-43. There will be a post-op visit sceduled approximately 4 weeks later.

Treatment Agents:	Sunitinib Malate	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to measure biomarker levels in your tumor tissue before and after treatment with sunitinib malate. The safety of sunitinib malate in patients who will be having surgery will also be studied.

Study Objectives / Outcomes

Primary Objective:

To evaluate apoptotic and proliferation indices demonstrated by pathologic (TUNEL, Ki-67 staining) measures in prostate cancer specimens before and after Sunitinib malate treatment.

Secondary Objectives:

To demonstrate that Sunitinib malate is safe and tolerable in patients who will be undergoing radical prostatectomy.
To describe any changes in angiogenic parameters including pathologic (microvessel density, endothelial/and pericyte staining) and systemic (plasma/urine levels of VEGF) before and during/following Sunitinib malate treatment.
To measure protein levels and activation status of PDGFR in prostate cancer tissue and to correlate changes associated with Sunitinib malate treatment to effects demonstrated by other measures (i.e. PSA, apoptosis, microvessel density).
To describe the gene expression patterns using microarray analysis associated with Sunitinib malate treatment.
To measure interstitial fluid pressure (IFP) pre-treatment and during treatment to indirectly measure the effect of Sunitinib malate on transcapillary transport and correlate with other biologic measures of treatment effect.

Study Status Information



Study Activation / Registration Date:	07/22/2009

IRB Review and Approval Date:	07/22/2009

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	30

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with histologic evidence of adenocarcinoma of the prostate who are deemed candidates for curative radical prostatectomy.

2) For All patients: Patients with intermediate or high risk, clinically localized disease by the following criteria (D'Amico criteria): a) PSA > 10 ng/ml or b) Gleason score 7-10 disease or c) T2b or greater disease or d) 3 or more positive biopsies on one side. For patients undergoing IFP measurement: Patients must have either palpable disease (T2b or greater) or 3 or more positive biopsies on one side. Up to 15 patients will be selected for this part of the study.

3) Adequate organ function as defined by the following criteria: a) Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) </= 2.5 x local laboratory upper limit of normal (ULN); b) Total serum bilirubin </= 1.5 x ULN; c) Absolute neutrophil count (ANC) >/= 1500/microL d) Platelets >/= 100,000/microL e) Hemoglobin >/= 9.0 g/dL; f) Serum calcium </= 12.0 mg/dL; g) Serum creatinine </= 1.5 x ULN h) Serum testosterone >/= 150 ng/mL

4) Patients must be surgically sterile or must agree to use effective contraception during the period of therapy.

5) Select imaging to rule out metastatic disease will be done as clinically indicated. Patients will not routinely receive bone scan /CT/MRI imaging unless there is clinical concern for possible metastatic disease.

6) Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

1) No prior treatment for prostate cancer

2) Major surgery or radiation therapy within 4 weeks of starting the study treatment.

3) NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.

4) History of or known metastatic prostate cancer

5) Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.

6) Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2.

7) QTc interval > 500 msec on baseline EKG

8) Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).

9) Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication

10) Known active infection

11) Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.

12) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Links

Registration Number: NCT00672594
Study Information on Clinical Trials Registry (clinicaltrials.gov)