Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer

Tracking Information
First Submitted Date ICMJE	May 29, 2002
First Posted Date ICMJE	May 30, 2002
Last Update Posted Date	August 1, 2012
Study Start Date ICMJE	October 2000
Actual Primary Completion Date	November 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00038181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
Official Title ICMJE	A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed by Radical Retropubic Prostatectomy (RRP) in Select Patients With Locally Advanced Prostate Cancer
Brief Summary	The goal of this clinical research study is to find out whether it is safe to treat patients diagnosed with locally advanced prostate cancer with the drug Thalidomide before removing the tumor (radical retropubic prostatectomy). Researchers also want to learn if Thalidomide can shrink or slow the growth of the prostate cancer before the surgery
Detailed Description	To determine the efficacy (rate of tumor reduction and PSA decline) of pre-operative treatment with thalidomide in patients with locally advanced prostate carcinoma.; To determine the safety and toxicity (excessive bleeding, wound healing problems) of preoperative therapy with thalidomide in patients with locally advanced prostate carcinoma who undergo RRP.; To obtain qualitative measurements of thalidomide's effect in vivo on: endothelial cells / neo-vascularity /angiogenic growth factors: Assessment of neovascularity (MVD) Dual fluorescent labeling technique to evaluate apoptosis in CD-31 positive cells (TUNEL) bFGF, VEGF, EGF and TGF expression by PCa epithelium and prostatic stroma Modulation of endothelial markers (serum: E-selectin and Thrombomodulin) Modulation of serum VEGF and urine bFGF levels, and Changes in tumor blood flow epithelial compartment: Apoptosis in prostate cancer cells (TUNEL) Proliferation (PCNA) quality of life
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Drug: Thalidomide
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 13, 2009)	18
Original Enrollment ICMJE; (submitted: June 23, 2005)	40
Actual Study Completion Date	November 2005
Actual Primary Completion Date	November 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria; Prostatic adenocarcinoma without evidence of regional or distant metastases, clinical stage T1c-T2c with Gleason score > 7 on initial biopsy and PSA > 10 ng/dl or clinical stage T3.; Negative bone scan and CT abd/pelvis.; Life expectancy of at least 10 years.; Surgical candidate for radical prostatectomy and ECOG performance status of < 2.; Patients must have no other concurrent malignancies (or within the past 5 years, with the exception of non-melanoma skin cancer or treated superficial transitional cell carcinoma of the bladder).; Peripheral granulocyte count > 1,500/mm3, platelet count of > 100,000/mm3 and Hb> 10.0 gm/dl, adequate hepatic function with a bilirubin < 1.5 mg % and SGPT < 2.5x the upper limits of normal, and adequate renal function defined as serum creatinine < 1.5 mg% or creatinine clearance > 40 ml/min.; Patients with biochemical hypothyroidism will have their thyroid hormone replaced concurrent with starting the study. Patients with clinical hypothyroidism should have their thyroid replaced prior to starting this study.; Informed consent indicating that patients are aware of the investigational nature of the study, in keeping with the policies of the institution. The only approved consent form is appended to this protocol.; Patients must be willing and able to travel to UT-MDACC for re-evaluation as necessary per protocol.; Patients should be counseled about the possibility that thalidomide may be present in the semen and must use a latex condom every time they have sexual intercourse with a woman during therapy and for 4 weeks after discontinuing thalidomide, even if they had a successful vasectomy. Exclusion criteria; Patients who have received any prior hormonal-, immuno-, radiation or chemo-therapy for prostate carcinoma are excluded from the trial. Prior herbal and/or homeopathic medication is allowed if discontinued at least 2 weeks prior to study entry. PC-SPES is considered hormonal therapy.; Patients with history of substantial non-iatrogenic bleeding diathesis and patients with macroscopic hematuria or active GI bleeding are not eligible.; Patients with uncontrolled cardiac, respiratory, hepatic, renal, neurologic or psychiatric disorder are excluded from the trial.; Patients with NCI grade 2 or greater peripheral neuropathy of any cause (clinically detectable), or receiving anti-convulsive medications are not eligible for this trial.; Patients who are receiving sedative/hypnotic agents which cannot be discontinued (if necessary) are not eligible for this study.; Patients positive for HIV are excluded from this trial.
Sex/Gender	Sexes Eligible for Study: Male
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00038181
Other Study ID Numbers ICMJE	ID00-089
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	M.D. Anderson Cancer Center
Study Sponsor ICMJE	M.D. Anderson Cancer Center
Collaborators ICMJE	Celgene Corporation
Investigators ICMJE	Not Provided
PRS Account	M.D. Anderson Cancer Center
Verification Date	July 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP