What side effects are associated with this type of intervention?

Common treatments for metastatic castration-resistant prostate cancer (CRPC) include androgen receptor inhibitors like enzalutamide and apalutamide, chemotherapy agents such as docetaxel, and radioligand therapies like lutetium Lu 177 vipivotide tetraxetan. The side effects of these treatments can vary but often include fatigue, hot flashes, hypertension, and gastrointestinal issues for androgen receptor inhibitors. Chemotherapy with docetaxel may cause neutropenia, febrile neutropenia, and neuropathy. Radioligand therapies can lead to myelosuppression, nephrotoxicity, and salivary gland toxicity. Enfortumab, being an antibody-drug conjugate, may share some of these side effects, particularly those related to immune responses and cytotoxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including antibody-drug conjugates and other targeted therapies. One notable approval is for lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy for PSMA-positive metastatic castration-resistant prostate cancer (CRPC), which has shown significant improvements in progression-free survival and overall survival. Additionally, treatments like sipuleucel-T, an autologous cellular immunotherapy, and radium-223, a radiopharmaceutical, have been approved for metastatic CRPC. While Enfortumab targets Nectin-4 and is being studied for prostate cancer, similar antibody-drug conjugates have not yet been specifically approved for prostate cancer treatment.

What other types of research exist?

Promising novel alternatives to Enfortumab for prostate cancer patients in 2024 include lutetium Lu 177 vipivotide tetraxetan, which has shown clinical efficacy in trials. Other emerging treatments and ongoing research should also be considered in consultation with a healthcare provider.

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Antibody-Drug Conjugate

Enfortumab Vedotin for Prostate Cancer (ENCORE Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth; chemotherapy, which uses drugs to kill rapidly dividing cancer cells; and immunotherapy, which boosts the body's immune system to fight cancer. Targeted therapies, such as Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, deliver cytotoxic agents directly to cancer cells, minimizing damage to normal cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's characteristics and the patient's overall health, potentially improving outcomes and reducing side effects.

Phase 2

Recruiting

Led By Umang Swami, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent

Castrate levels of testosterone as defined as < 50 ng/dL (1.73 nmol/L).

Must not have

Clinically significant cardiovascular disease: myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.

Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing enfortumab, a drug that targets and kills cancer cells, in patients with prostate cancer that has spread and does not respond to hormone treatments. The goal is to see how well enfortumab works in these patients.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to castration and has worsened after hormone therapy. They must have had prior chemotherapy, maintain low testosterone levels, and have good organ function. Participants need to agree to effective contraception and not have HIV or hepatitis with detectable viral loads.

What is being tested?

The trial is testing Enfortumab Vedotin alone or with other anti-cancer drugs in men whose prostate cancer has spread and doesn't respond to hormone treatment anymore. It's an open-label phase II study where everyone knows what treatment they're getting.

What are the potential side effects?

Enfortumab Vedotin may cause side effects like fatigue, rash, decreased appetite, neuropathy (nerve pain), blood sugar changes, infusion-related reactions, as well as liver and kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has spread and cannot be removed by surgery.

Select...

My testosterone levels are very low, below 50 ng/dL.

Select...

I can take care of myself and perform daily activities.

Select...

My prostate cancer is confirmed without being a small cell type.

Select...

I am a man aged 18 or older.

Select...

I have been treated with a newer hormone therapy for my cancer.

Select...

My blood, liver, and kidney functions meet the required levels for the study.

Select...

I stopped all cancer treatments (except hormone therapy and bone treatments) 28 days ago.

Select...

My condition worsened after hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have serious heart conditions like recent heart attacks or severe heart failure.

Select...

I have not received any live vaccines within the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion subjects achieving one of the following: Objective response by RECIST1.1, Confirmed conversion of circulating tumor cell count (CTC) to <5/7.5 mL blood, PSA decline ≥ 50% from baseline, or Stable disease ≥ 6 months per PCWG3 mod.RECIST 1.1

Side effects data

From 2023 Phase 2 trial • 219 Patients • NCT03219333

53%

Fatigue

51%

Alopecia

51%

Decreased appetite

45%

Nausea

43%

Peripheral sensory neuropathy

42%

Diarrhoea

39%

Dysgeusia

35%

Anaemia

32%

Weight decreased

28%

Dry skin

28%

Constipation

27%

Pruritus

25%

Oedema peripheral

24%

Dry eye

23%

Rash maculo-papular

19%

Vomiting

18%

Abdominal pain

17%

Lacrimation increased

17%

Back pain

16%

Dizziness

16%

Vision blurred

16%

Cough

15%

Aspartate aminotransferase increased

14%

Hyperglycaemia

14%

Urinary tract infection

14%

Insomnia

13%

Hypokalaemia

13%

Lipase increased

12%

Hyponatraemia

12%

Pyrexia

12%

Dyspnoea

12%

Rash erythematous

12%

Alanine aminotransferase increased

11%

Arthralgia

11%

Fall

11%

Pain in extremity

11%

Peripheral motor neuropathy

10%

Dehydration

10%

Neutropenia

10%

Skin hyperpigmentation

10%

Amylase increased

Dry mouth

Blood creatinine increased

Stomatitis

Malaise

Muscular weakness

Haematuria

Myalgia

Punctate keratitis

Tachycardia

Hypotension

Gastrooesophageal reflux disease

Lymphocyte count decreased

Blepharitis

Dysphagia

Rhinorrhoea

Pneumonia

Blood alkaline phosphatase increased

Cellulitis

Musculoskeletal pain

Dysphonia

Oral candidiasis

Hyperuricaemia

Hypophosphataemia

Asthenia

Gait disturbance

Hypertension

Skin exfoliation

White blood cell count decreased

Dysuria

Rash macular

Abdominal pain upper

Headache

Chills

Febrile neutropenia

Sepsis

Acute kidney injury

Infusion related reaction

Hypoalbuminaemia

Abdominal distension

Paraesthesia

Anxiety

Pollakiuria

Spinal cord compression

Hypoxia

Pneumonia aspiration

Deep vein thrombosis

Hyperkalaemia

Hypercalcaemia

Pulmonary embolism

Transitional cell carcinoma metastatic

Urinary tract obstruction

Rash vesicular

Colitis

Infusion site extravasation

Acute respiratory failure

Delirium

Urinary tract infection staphylococcal

Drug eruption

Pleural effusion

Palpitations

Incarcerated hernia

Device related infection

Neutrophil count decreased

Infection

Compression fracture

Aortic stenosis

Cancer pain

Transitional cell carcinoma

Interstitial lung disease

Embolism

Wound

Hypoglycaemia

Hypomagnesaemia

Colon cancer

Encephalopathy

Confusional state

Stevens-Johnson syndrome

Gastrointestinal haemorrhage

Enterocolitis

Cardiac disorder

Large intestinal obstruction

Odynophagia

Small intestinal obstruction

Bile duct stone

100%

80%

60%

40%

20%

Study treatment Arm

Enfortumab Vedotin - Cohort 1

Enfortumab Vedotin - Cohort 2

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: Treatment: all patientsExperimental Treatment1 Intervention

Enfortumab will be administered in monotherapy on days 1, 8, and 15 as part of a 28-day cycle at 1.25 mg/kg up to 125 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enfortumab vedotin

2017

Completed Phase 2

~240

0 / 11Eligibility 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

Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth; chemotherapy, which uses drugs to kill rapidly dividing cancer cells; and immunotherapy, which boosts the body's immune system to fight cancer. Targeted therapies, such as Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, deliver cytotoxic agents directly to cancer cells, minimizing damage to normal cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's characteristics and the patient's overall health, potentially improving outcomes and reducing side effects.