Prostate CancerPhase 2NCT00183937
Study of Bortezomib and Docetaxel for Patients With Hormone Refractory Prostate Cancer
A Phase 2 study testing PS 341 and Docetaxel in people with Prostate Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This study is for patients who have been treated with surgical removal of the testes or hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PS 341 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2005to 11 Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have had a histological or cytological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormone therapy. Patients must have metastatic prostate cancer deemed to be hormone refractory by one or more of the following (despite androgen ablation and anti-androgen withdrawal where applicable):
- Progression of measurable disease assessed within 28 days prior to registration. OR
- Progression of non-measurable (i.e. bone scan or PET scan) disease assessed within 42 days prior to registration. AND
- Rising PSA - defined as at least 2 consecutive rises in PSA documented over a reference value (measure 1). The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater then the second measure and it must be obtained at least 7 days after the 2nd measure. Patient must have a PSA concentration of at least 5 ng/ml in addition to increasing PSA to be eligible Note: The PSA result (done within 28 days prior to registration) need not be elevated for inclusion provided other criteria for progression are met and the serum PSA is at least 2 ng/ml.
- Must have received prior hormonal therapy and have a castrate level of testosterone (less than 100ng/ml within 90 days of entry to the study). Patients treated with orchiectomy are eligible. If patients have been treated with non-steroidal anti-androgens, the patients must have ceased taking flutamide or nilutamide at least 28 days prior to enrollment and at least 42 days prior to enrollment for biclutamide. Either method of castration can have been supplemented with nonsteroidal antiandrogen (e.g. flutamide, biclutamide, nilutamide). Patients may have been treated with "second-line" hormonal therapy such as ketoconazole, aminoglutethimide and/or estrogen therapies but these must have ceased at least 7 days prior to commencement of study therapy.
- May have received at most one prior chemotherapy for hormone refractory prostate cancer provided they have not received docetaxel or Bortezomib for that indication or otherwise within 2 years of trial entry.
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- Prior radiation therapy is allowed but it must have been to less than 25% of total body bone marrow. This includes prior use of samarium, but patients can not have received strontium. (>10 days must have elapsed since completion of RT with recovery from side effects. Soft tissue disease irradiated in the prior 2 months is not and may not be designated as measurable
- Creatinine less than or equal to 1.5x the institutional upper limit of normal (within 28 days prior to registration)
- Hepatic function Total Bilirubin less than or equal to ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
- In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
- Adequate bone marrow function. Complete blood count with differential must be done within 14 days prior to registration Absolute neutrophil count greater than or equal to 1,500/mm3 Hemoglobin greater than or equal to 8.0 g/dl Platelet count greater than or equal to 100,000/mm3
- ECOG performance status 0-3. (For patients with PS of 3, cause must be due to pain secondary to bone metastases to be eligible)
- Patients should (for good medical practice) have stabilization of their analgesic medications for at least one week prior to receiving study medication
- No other chemotherapy, biological response modifiers, RT, radioisotope therapy (e.g. samarium or strontium), corticosteroid, or concomitant hormonal therapy may be given during protocol treatment.
- Bisphosphonate therapy is permitted provided it commences prior to study entry and is maintained at recommended dosing intervals.
- Completed baseline McGill Pain Questionnaire and Pain Medication Log prior to registration. The nurse or CRA must complete MPQ and PML cover sheet for baseline assessment prior to registration. If unable to complete questionnaires in English or Spanish, patient can be registered without contributing to QOL study).
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period (90 days) thereafter.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Myocardial infarction or angina pectoris within one year of registration
- History of brain metastases, treated or untreated. (Patients with neurological symptoms must have CT or MRI brain negative for metastatic disease within 56 days prior to registration). Patients who have recovered from spinal cord compression and are clinical stable may enter the study provided they fulfill other criteria.
- Not recovered from major infections and/or surgical procedures, or has significant active concurrent other medical illness precluding protocol therapy or survival.
- Known or anticipated severe hypersensitivity reaction to bortezomib, boron, mannitol, docetaxel or polysorbate 80.
- Other prior malignancy (except patients who have had another stage I or II malignancy currently in complete remission or other cancer with no evidence of disease for greater than 5 years from accrual to the current trial. Patients with basal or squamous cell carcinoma of the skin that have been treated with curative intent can be accrued to this trial 30 days after treatment. Solar keratoses treated topically do not preclude entry).
- Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment.
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- Prior therapy with docetaxel or paclitaxel
- Prior treatment with more than one prior chemotherapy for hormone refractory prostate cancer.
- Ongoing therapy with drugs known to inhibit P4503A4 drug metabolism including:
- Macrolide antibiotics: erythromycin, troleandomycin, azithromycin Imidazole antifungal agents: ketoconazole, itraconazole, fluconazole HIV protease inhibitors Immunosuppressive agents: cyclosporin, FK-506
- Ongoing therapy with drugs known to induce P4503A4 drug metabolism including: Phenobarbital, phenytoin, carbamazepine, griseofuvin and rifampin.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Phase II Study of Bortezomib (Velcade®, PS-341) and Docetaxel for Patients With Hormone Refractory Prostate Cancer
This study is for patients who have been treated with surgical removal of the testes or hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this treatment.
PS 341 is a type of drug known as a "proteasome inhibitor." By inhibiting the "proteasome" in cancer cells, PS-341 alters the way those cells divide). We hope to learn whether this combination chemotherapy decreases cancer symptoms and tests (prostate specific antigen, also called PSA), and to determine how frequently serious side effects might occur with this treatment for this stage of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- PS 341, Docetaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS 341Drug
Also called Bortezomib, Velcade
PS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles.
DocetaxelDrug
Docetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib and Docetaxel | Experimental | Bortezomib 1.6 mg/m2 Docetaxel 75 mg/m2 Receives: Drug: PS 341; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Response Rate
Participants should be reevaluated for PSA response every 21 days. A confirmatory PSA level should be obtained 3-4 weeks following initial documentation of a PSA response.
Measured: Every end of each cycle (21 days) up to 12 cycles
Secondary outcomes (3)
Pain Response Rate
Participants will be considered evaluable for a pain response if the baseline analgesic use was determined, and at least 4 weekly assessments of PPI and analgesic score are available from any 8-week period from the period after the initiation of therapy until discontinuation of study medication.
Measured: At baseline, then weekly for 4 weeks up to 36 weeks
RECIST Response
Measured: At 4 weeks after the last dose of study drug, up to 3 years.
Therapeutic Toxicity Assessment
Each adverse event will be determined by using the NCI CTCAE, version 3.0.
Measured: At 3 weeks after the last dose of study drug, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start30 Apr 2005
- Primary completion23 Oct 2010
- Study completion11 Jun 2012
Why it stopped: Sponsor stopped study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- David Quinn, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183937
- Sponsor's protocol ID
- 4P-04-3
- Status last verified
- May 2026
- First submitted
- 9 Sep 2005
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bortezomib (Velcade®, PS-341) and Docetaxel for Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00183937
- Acronym / sponsor ID
- 4P-04-3
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped study early.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 30 Apr 2005 (actual)
- Primary completion
- 23 Oct 2010 (actual)
- Study completion
- 11 Jun 2012 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients who have been treated with surgical removal of the testes or hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this treatment.
PS 341 is a type of drug known as a "proteasome inhibitor." By inhibiting the "proteasome" in cancer cells, PS-341 alters the way those cells divide). We hope to learn whether this combination chemotherapy decreases cancer symptoms and tests (prostate specific antigen, also called PSA), and to determine how frequently serious side effects might occur with this treatment for this stage of prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib and Docetaxel | Experimental | Drug: PS 341, Drug: DocetaxelBortezomib 1.6 mg/m2 Docetaxel 75 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient must have had a histological or cytological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormone therapy. Patients must have metastatic prostate cancer deemed to be hormone refractory by one or more of the following (despite androgen ablation and anti-androgen withdrawal where applicable):
- Progression of measurable disease assessed within 28 days prior to registration. OR
- Progression of non-measurable (i.e. bone scan or PET scan) disease assessed within 42 days prior to registration. AND
- Rising PSA - defined as at least 2 consecutive rises in PSA documented over a reference value (measure 1). The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater then the second measure and it must be obtained at least 7 days after the 2nd measure. Patient must have a PSA concentration of at least 5 ng/ml in addition to increasing PSA to be eligible Note: The PSA result (done within 28 days prior to registration) need not be elevated for inclusion provided other criteria for progression are met and the serum PSA is at least 2 ng/ml.
- Must have received prior hormonal therapy and have a castrate level of testosterone (less than 100ng/ml within 90 days of entry to the study). Patients treated with orchiectomy are eligible. If patients have been treated with non-steroidal anti-androgens, the patients must have ceased taking flutamide or nilutamide at least 28 days prior to enrollment and at least 42 days prior to enrollment for biclutamide. Either method of castration can have been supplemented with nonsteroidal antiandrogen (e.g. flutamide, biclutamide, nilutamide). Patients may have been treated with "second-line" hormonal therapy such as ketoconazole, aminoglutethimide and/or estrogen therapies but these must have ceased at least 7 days prior to commencement of study therapy.
Key exclusion criteria (11 listed)
- Myocardial infarction or angina pectoris within one year of registration
- History of brain metastases, treated or untreated. (Patients with neurological symptoms must have CT or MRI brain negative for metastatic disease within 56 days prior to registration). Patients who have recovered from spinal cord compression and are clinical stable may enter the study provided they fulfill other criteria.
- Not recovered from major infections and/or surgical procedures, or has significant active concurrent other medical illness precluding protocol therapy or survival.
- Known or anticipated severe hypersensitivity reaction to bortezomib, boron, mannitol, docetaxel or polysorbate 80.
- Other prior malignancy (except patients who have had another stage I or II malignancy currently in complete remission or other cancer with no evidence of disease for greater than 5 years from accrual to the current trial. Patients with basal or squamous cell carcinoma of the skin that have been treated with curative intent can be accrued to this trial 30 days after treatment. Solar keratoses treated topically do not preclude entry).
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 |
|---|---|---|
| PS 341Also: Bortezomib, VelcadePS 341 1.6 mg/m2 IV (in the vein) on days 1 and 8 of each 21 day cycle up to 12 cycles. | Drug | Bortezomib and Docetaxel |
| DocetaxelDocetaxel 75mg/m2 IV (in the vein) on day 1 of each 21 day cycle up to 12 cycles. | Drug | Bortezomib and Docetaxel |
Primary outcome
PSA Response Rate
Time frame: Every end of each cycle (21 days) up to 12 cycles
Participants should be reevaluated for PSA response every 21 days. A confirmatory PSA level should be obtained 3-4 weeks following initial documentation of a PSA response.
3 secondary outcomes
Pain Response Rate
Time frame: At baseline, then weekly for 4 weeks up to 36 weeks
RECIST Response
Time frame: At 4 weeks after the last dose of study drug, up to 3 years.
Therapeutic Toxicity Assessment
Time frame: At 3 weeks after the last dose of study drug, up to 3 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Quinn, MD principal investigator
University of Southern California
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 PS 341 and Docetaxel in people with Prostate Cancer, run by University of Southern California 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 18 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 May 2026. 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?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
PSA Response Rate (time frame: Every end of each cycle (21 days) up to 12 cycles). It is what the study was designed to measure, not a finding.
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 May 2026.