What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including proteasome inhibitors like bortezomib, can have several side effects. Bortezomib is associated with peripheral neuropathy, gastrointestinal issues, fatigue, and hematologic toxicities such as thrombocytopenia, anemia, and neutropenia. Other prostate cancer treatments, such as androgen receptor therapies (e.g., enzalutamide and abiraterone), can cause fatigue, hypertension, and liver function abnormalities. Chemotherapy agents like docetaxel may lead to neutropenia, febrile neutropenia, and gastrointestinal disturbances. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, particularly for castration-resistant prostate cancer (CRPC). These include androgen receptor inhibitors like enzalutamide, apalutamide, and darolutamide, as well as androgen biosynthesis inhibitors like abiraterone. Additionally, radioligand therapy with lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive metastatic CRPC. While bortezomib, a proteasome inhibitor, is being studied for its efficacy in metastatic castration-resistant prostate cancer with PTEN deletion, it has not yet been approved for this specific indication. Other proteasome inhibitors have not been prominently featured in the treatment landscape for prostate cancer.

What other types of research exist?

Promising novel alternatives to Bortezomib for prostate cancer patients include: 1) Taxane-based regimens such as Docetaxel and Cabazitaxel, which have shown higher rates of tumor regression and longer overall survival. 2) Immunotherapy options like Pembrolizumab for patients with tumors having dMMR or high TMB. 3) PARP inhibitors such as Olaparib and Niraparib for patients with homologous recombination repair deficiency. 4) Lutetium-177-PSMA-617, a radioligand therapy targeting PSMA-positive mCRPC.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ until end of study. study anticipated to be about 4 years.

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%

Cough

29%

Thrombocytopenia

29%

Nausea

29%

Decreased appetite

21%

Anaemia

21%

Constipation

21%

Diarrhoea

21%

Fatigue

14%

Oedema peripheral

14%

Pneumonia

14%

Neuropathy peripheral

14%

Paraesthesia

14%

Cataract

14%

Vomiting

14%

Headache

Fungal skin infection

Urinary tract infection

Asthma

Respiratory syncytial virus infection

Neutropenia

Peripheral swelling

Mental status changes

Lower respiratory tract infection

Hyperthyroidism

Back pain

Pain in extremity

Hyponatraemia

Skin lesion

Oropharyngeal pain

Pyrexia

Disturbance in attention

Cardiac failure

Hepatitis

Pharyngitis

Pollakiuria

Non-cardiac chest pain

C-reactive protein increased

Taste disorder

Haemorrhagic transformation stroke

Abdominal pain

Insomnia

Dyspepsia

Haemoglobin decreased

Infection

Hyperglycaemia

Toothache

Ecchymosis

Upper respiratory tract infection

Nasopharyngitis

Viral infection

Hypertension

Muscular weakness

Bronchiectasis

Hypophagia

Basal cell carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

SdX Arm: Selinexor + Dexamethasone

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met

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.