Metastatic Castration-resistant Prostate CancerPhase 2BORXPTENNCT06029998
Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion
A Phase 2 study testing Bortezomib in people with Metastatic Castration-resistant Prostate Cancer, run by University of Utah at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the anti-tumor activity of bortezomib in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) with PTEN Deletion. The main question[s] it aims to answer is if the use of bortezomib will result in a decline in PSA for participants. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male subject aged ≥ 18 years
- Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
- Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L)
- Prior treatment with at least one prior Androgen Receptor Pathway Inhibitor (ARPI), defined as second-generation anti-androgen therapies that include, but are not limited to, abiraterone acetate, enzalutamide, apalutamide, and darolutamide.
- No prior systemic chemotherapy treatment for mCRPC disease (e.g., docetaxel, or cabazitaxel).
- Available tumor tissue (archival tissue, or, if no archival tissue is available, must be able to undergo biopsy for fresh tumor tissue). If tumor tissue is unavailable, results of ATAD1 immunohistochemistry must be available.
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- PTEN deletion on next generation sequencing
- Must have progressive mCRPC per the treating investigator
- ECOG Performance Status ≤ 2.
- Adequate organ function as defined as:
- Hematologic:
- Absolute neutrophil count ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 10 g/dL
- Hepatic:
- Total bilirubin ≤ 1.5 times ULN
- Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment in accordance with section 5.4.3.
- Recovery to baseline or grade ≤ 1 CTCAE V5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per treating investigator.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Patients must have a life expectancy > 3 months.
Who cannot join
- Neuropathy grade ≥ 2
- Receiving other investigational agents.
- Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter. Patients can continue ADT and bone strengthening agents while on treatment.
- Prior radiotherapy within 14 days prior to the first dose of study treatment.
- --Note: Palliative radiation therapy may be completed up to 14 days prior to starting study therapy provided that no clinically significant treatment related toxicities are present at the time of study therapy initiation per treating investigator.
- Major surgery within 14 days prior to starting study drug or who have not fully recovered from major surgery per treating investigator.
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- The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration per treating investigator (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix).
- Known brain metastases or cranial epidural disease.
- --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis (DVT), pulmonary embolism (PE)) within 3 months before the first dose. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 3 months are allowed if stable, asymptomatic, and treated with a stable dose of anticoagulation for at least 1 week before first dose of study treatment.
- Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment. If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.
- Known congenital long QT.
- Left ventricular ejection fraction < 50%.
- Uncontrolled hypertension defined as sustained blood pressure (BP) ≥ 150 mm Hg systolic or >90 mm Hg diastolic despite optimal antihypertensive treatment.
- Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, social/ psychological issues, etc.)
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
- --Note: Participants on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
- Systemic known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C. Patients do not need to be tested for trial enrollment unless clinical suspicion is present.
- --Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Medical, psychiatric, cognitive, or other conditions that per treating investigator may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
- Participants taking prohibited medications as described in Section 6.7.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Phase II Study of Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion
The goal of this clinical trial is to test the anti-tumor activity of bortezomib in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) with PTEN Deletion.
The main question[s] it aims to answer is if the use of bortezomib will result in a decline in PSA for participants.
Participants will receive a sub-cutaneous injection of bortezomib for up 8 cycles. Each cycle is about 21 days.
- Being tested
- Bortezomib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
sub-cutaneous injection of bortezomib for 6-8 cycles of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib | Experimental | bortezomib starting at a dose of 1.3 mg per square meter of the body-surface area (BSA) subcutaneously on days 1, 4, 8, and 11 in a 21-day cycle. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving PSA decline of ≥ 30% from baseline will be considered a response.
To evaluate the antitumor activity of bortezomib in patients with metastatic castration-resistant prostate cancer (mCRPC) with PTEN deletion as assessed by prostate-specific antigen (PSA) 30% response rate.
Measured: Up to 6-8 cycles of treatment. Each cycle is 21 days.
Secondary outcomes (13)
The proportion of patients achieving PSA decline of ≥ 50% (PSA50) compared to the baseline value prior to starting study treatment.
To assess the PSA 50% response rate in the study population.
Measured: Up to 6-8 cycles of treatment. Each cycle is 21 days.
Duration of PSA response as defined as the interval of time from PSA decline of ≥ 50% to PSA progression as defined by PCWG3 criteria.
To assess duration of PSA response in the study population.
Measured: Until progression or end of study. Study anticipated to be about 4 years.
PSA PFS as defined as the interval of time from study drug initiation to the time of PSA progression as defined by PCWG3 criteria.
To assess the PSA progression-free survival (PSA PFS) in the study population.
Measured: Until progression or end of study. Study anticipated to be about 4 years.
ORR as defined as the proportion of patients with measurable disease achieving a confirmed partial response (PR) and complete response (CR) as assessed by PCWG3-modified RECIST
To assess the objective response rate (ORR) in the study population.
Measured: Until progression or end of study. Study anticipated to be about 4 years.
DoR as defined as the interval of time from the date of initial documented response (PR or better per PCWG3-modified RECIST 1.1) to the time of progression, the start of a new therapy, or death from any cause.
To assess the duration of response (DoR) in the study population.
Measured: Until progression or end of study. Study anticipated to be about 4 years.
rPFS as defined as the time from study drug initiation to the time of radiographic disease progression as assessed by PCWG3 modified RECIST 1.1 or death from any cause.
To assess radiographic progression-free survival (rPFS)
Measured: Until progression or end of study. Study anticipated to be about 4 years.
PFS as defined as the time from study drug initiation to the time of disease progression (clinical or radiological as assessed by PCWG3 modified RECIST 1.1) or death from any cause.
To assess PFS in the study population.
Measured: Until progression or end of study. Study anticipated to be about 4 years.
OS as defined as the time from study drug initiation until death from any cause.
To assess overall survival (OS) in this study population.
Measured: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
To assess the safety of bortezomib in study population.
Measured: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).
To assess the safety of bortezomib in study population.
Measured: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
To assess the safety of bortezomib in study population.
Measured: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
To assess the safety of bortezomib in study population.
Measured: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
To assess the safety of bortezomib in study population.
Measured: Until end of study. Study anticipated to be about 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start11 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Model description
- A modified intent-to-treat data set will be used for both safety and efficacy endpoint analysis. All participants who have received one dose of study medication will be included in all efficacy and safety data sets. Participants who fail to begin study therapy will be replaced.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Umang Swami, MD, MS, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029998
- Sponsor's protocol ID
- HCI168505
- Acronym
- BORXPTEN
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bortezomib in Patients With Metastatic Castration-Resistant Prostate Cancer With PTEN Deletion
- ClinicalTrials.gov ID
- NCT06029998
- Acronym / sponsor ID
- BORXPTEN / HCI168505
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Sep 2023 (actual)
- 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 trial is to test the anti-tumor activity of bortezomib in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) with PTEN Deletion.
The main question[s] it aims to answer is if the use of bortezomib will result in a decline in PSA for participants.
Participants will receive a sub-cutaneous injection of bortezomib for up 8 cycles. Each cycle is about 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A modified intent-to-treat data set will be used for both safety and efficacy endpoint analysis. All participants who have received one dose of study medication will be included in all efficacy and safety data sets. Participants who fail to begin study therapy will be replaced.
| Arm | Type | Receives |
|---|---|---|
| Bortezomib | Experimental | Drug: Bortezomibbortezomib starting at a dose of 1.3 mg per square meter of the body-surface area (BSA) subcutaneously on days 1, 4, 8, and 11 in a 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male subject aged ≥ 18 years
- Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
- Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L)
- Prior treatment with at least one prior Androgen Receptor Pathway Inhibitor (ARPI), defined as second-generation anti-androgen therapies that include, but are not limited to, abiraterone acetate, enzalutamide, apalutamide, and darolutamide.
- No prior systemic chemotherapy treatment for mCRPC disease (e.g., docetaxel, or cabazitaxel).
Key exclusion criteria (25 listed)
- Neuropathy grade ≥ 2
- Receiving other investigational agents.
- Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter. Patients can continue ADT and bone strengthening agents while on treatment.
- Prior radiotherapy within 14 days prior to the first dose of study treatment.
- --Note: Palliative radiation therapy may be completed up to 14 days prior to starting study therapy provided that no clinically significant treatment related toxicities are present at the time of study therapy initiation per treating investigator.
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 |
|---|---|---|
| Bortezomibsub-cutaneous injection of bortezomib for 6-8 cycles of treatment. | Drug | Bortezomib |
Primary outcome
The proportion of patients achieving PSA decline of ≥ 30% from baseline will be considered a response.
Time frame: Up to 6-8 cycles of treatment. Each cycle is 21 days.
To evaluate the antitumor activity of bortezomib in patients with metastatic castration-resistant prostate cancer (mCRPC) with PTEN deletion as assessed by prostate-specific antigen (PSA) 30% response rate.
13 secondary outcomes
The proportion of patients achieving PSA decline of ≥ 50% (PSA50) compared to the baseline value prior to starting study treatment.
Time frame: Up to 6-8 cycles of treatment. Each cycle is 21 days.
Duration of PSA response as defined as the interval of time from PSA decline of ≥ 50% to PSA progression as defined by PCWG3 criteria.
Time frame: Until progression or end of study. Study anticipated to be about 4 years.
PSA PFS as defined as the interval of time from study drug initiation to the time of PSA progression as defined by PCWG3 criteria.
Time frame: Until progression or end of study. Study anticipated to be about 4 years.
ORR as defined as the proportion of patients with measurable disease achieving a confirmed partial response (PR) and complete response (CR) as assessed by PCWG3-modified RECIST
Time frame: Until progression or end of study. Study anticipated to be about 4 years.
DoR as defined as the interval of time from the date of initial documented response (PR or better per PCWG3-modified RECIST 1.1) to the time of progression, the start of a new therapy, or death from any cause.
Time frame: Until progression or end of study. Study anticipated to be about 4 years.
rPFS as defined as the time from study drug initiation to the time of radiographic disease progression as assessed by PCWG3 modified RECIST 1.1 or death from any cause.
Time frame: Until progression or end of study. Study anticipated to be about 4 years.
PFS as defined as the time from study drug initiation to the time of disease progression (clinical or radiological as assessed by PCWG3 modified RECIST 1.1) or death from any cause.
Time frame: Until progression or end of study. Study anticipated to be about 4 years.
OS as defined as the time from study drug initiation until death from any cause.
Time frame: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Time frame: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).
Time frame: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Time frame: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Time frame: Until end of study. Study anticipated to be about 4 years.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
Time frame: Until end of study. Study anticipated to be about 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Umang Swami, MD, MS principal investigator
University of Utah
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 Bortezomib in people with Metastatic Castration-resistant Prostate Cancer, run by University of Utah 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 20 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
The proportion of patients achieving PSA decline of ≥ 30% from baseline will be considered a response. (time frame: Up to 6-8 cycles of treatment. Each cycle is 21 days.). 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 7 Jul 2026.