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Proteasome Inhibitor

Bortezomib for Prostate Cancer (BORXPTEN Trial)

Phase 2
Recruiting
Led By Umang Swami, MD, MS
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status ≤ 2
Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
Must not have
Prior radiotherapy within 14 days prior to the first dose of study treatment
Known brain metastases or cranial epidural disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until end of study. study anticipated to be about 4 years.
Awards & highlights

Summary

This trial tests if a drug, bortezomib, can help treat prostate cancer in those with PTEN deletion. Patients receive 8 cycles of injections to see if it helps reduce PSA.

Who is the study for?
Men over 18 with advanced prostate cancer resistant to hormone therapy and no prior mCRPC treatments can join. They must have a life expectancy over 3 months, treated or stable other cancers, good organ function, and agree to use contraception. Excluded are those with severe heart issues, active infections like TB or hepatitis B/C, recent major surgery or therapies, brain metastases, uncontrolled blood pressure or HIV.
What is being tested?
The trial tests bortezomib's effectiveness in reducing PSA levels in men with metastatic castration-resistant prostate cancer that has a specific genetic change (PTEN deletion). Participants will receive subcutaneous injections of bortezomib for up to eight cycles lasting about three weeks each.
What are the potential side effects?
Bortezomib may cause side effects such as nerve damage (neuropathy), fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems. Heart rhythm issues could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My prostate cancer is confirmed without being a small cell type.
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I have undergone orchiectomy or am on hormone therapy with low testosterone levels.
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My cancer has a PTEN gene deletion.
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I have been treated with medications like abiraterone or enzalutamide for my cancer.
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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had radiotherapy in the last 14 days.
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I have brain metastases or cranial epidural disease.
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I do not have severe heart failure, unstable chest pain, or serious heart rhythm problems.
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My high blood pressure is not controlled even with medication.
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I have moderate to severe nerve pain or damage.
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I haven't had major surgery in the last 2 weeks or have fully recovered from one.
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I have a known long QT syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until end of study. study anticipated to be about 4 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and until end of study. study anticipated to be about 4 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of patients achieving PSA decline of ≥ 30% from baseline will be considered a response.
Secondary study objectives
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.
Duration of PSA response as defined as the interval of time from PSA decline of ≥ 50% to PSA progression as defined by PCWG3 criteria.
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
+10 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562
43%
Weight decreased
29%
Decreased appetite
29%
Nausea
29%
Cough
29%
Thrombocytopenia
21%
Constipation
21%
Diarrhoea
21%
Anaemia
21%
Fatigue
14%
Neuropathy peripheral
14%
Paraesthesia
14%
Cataract
14%
Vomiting
14%
Headache
14%
Oedema peripheral
14%
Pneumonia
7%
Peripheral swelling
7%
Non-cardiac chest pain
7%
Infection
7%
Bronchiectasis
7%
Lower respiratory tract infection
7%
Hyperglycaemia
7%
Toothache
7%
Ecchymosis
7%
Back pain
7%
Pain in extremity
7%
Fungal skin infection
7%
Respiratory syncytial virus infection
7%
Pharyngitis
7%
Asthma
7%
Haemorrhagic transformation stroke
7%
Urinary tract infection
7%
Basal cell carcinoma
7%
Skin lesion
7%
Abdominal pain
7%
Insomnia
7%
Dyspepsia
7%
Haemoglobin decreased
7%
Disturbance in attention
7%
Hyponatraemia
7%
Hypophagia
7%
Oropharyngeal pain
7%
Hypertension
7%
Viral infection
7%
C-reactive protein increased
7%
Muscular weakness
7%
Taste disorder
7%
Neutropenia
7%
Pyrexia
7%
Upper respiratory tract infection
7%
Nasopharyngitis
7%
Cardiac failure
7%
Hyperthyroidism
7%
Hepatitis
7%
Mental status changes
7%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
SdX Arm: Selinexor + Dexamethasone
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
SVd Arm: Selinexor + Bortezomib + Dexamethasone
Vd Arm: Bortezomib + Dexamethasone

Trial Design

1Treatment groups
Experimental Treatment
Group I: BortezomibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 3
~1410

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often target the androgen receptor signaling pathway, crucial for prostate cancer cell growth. Androgen receptor inhibitors like enzalutamide block androgen binding, nuclear translocation, and DNA association, effectively reducing cancer cell proliferation. Proteasome inhibitors, such as bortezomib, disrupt protein degradation, leading to cancer cell apoptosis. Radioligand therapies, like lutetium Lu 177 vipivotide tetraxetan, deliver targeted radiation to cancer cells, minimizing damage to surrounding tissues. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics and progression.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,127 Previous Clinical Trials
1,793,175 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
Umang Swami, MD, MSPrincipal InvestigatorUniversity of Utah
~15 spots leftby Dec 2025
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