Prostate CancerPhase 2NCT00038181
Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
A Phase 2 study testing Thalidomide in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Thalidomide
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2000to 29 Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Prostate Cancer
- Being tested
- Thalidomide
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study start5 Oct 2000
- Primary completion29 Nov 2005
- Study completion29 Nov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038181
- Sponsor's protocol ID
- ID00-089
- Status last verified
- Nov 2018
- First submitted
- 29 May 2002
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00038181
- Acronym / sponsor ID
- ID00-089
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 5 Oct 2000 (actual)
- Primary completion
- 29 Nov 2005 (actual)
- Study completion
- 29 Nov 2005 (actual)
- First posted
- 30 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.