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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00038181
• Collaborator: Celgene (Industry)
• Enrollment: 18
• Location: 1
• Actual Duration (Months): 61.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Thalidomide	Phase 2

Detailed Description

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:

4. 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

1. epithelial compartment:

• Apoptosis in prostate cancer cells (TUNEL)

• Proliferation (PCNA)

1. quality of life

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed by Radical Retropubic Prostatectomy (RRP) in Select Patients With Locally Advanced Prostate Cancer
• Actual Study Start Date: Oct 5, 2000
• Actual Primary Completion Date: Nov 29, 2005
• Actual Study Completion Date: Nov 29, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• Celgene

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00038181
• Other Study ID Numbers: ID00-089; NCT00080652
• First Posted: May 30, 2002
• Last Update Posted: Nov 15, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by M.D. Anderson Cancer Center: Prostate Cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Thalidomide

Study Results

No Results Posted as of Nov 15, 2018