|
Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer Clinical research trials and Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer. Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer  Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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
Details: 1.To determine the efficacy (rate of tumor reduction and PSA decline) of pre-operative treatment with thalidomide in patients with locally advanced prostate carcinoma. 2.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. 3.To obtain qualitative measurements of thalidomide's effect in vivo on: a) 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 b)epithelial compartment: - Apoptosis in prostate cancer cells (TUNEL) - Proliferation (PCNA) c)quality of life
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: 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.
Total Enrollment: 40
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Christopher Logothetis 713-792-2830
Additional Information:
Study ID Numbers: ID00-089;
Study Start Date: October 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038181
Other Prostate Cancer Studies:
1. ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
2. Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer
3. Selenium and Vitamin E in Preventing Prostate Cancer
4. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
5. YM598 in patients with rising PSA after initial therapy for localized prostate cancer
Related Studies:
Other Prostate Cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
|
|
|
|
|
|
|
|
