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Alkylating agents

Cyclophosphamide + Dexamethasone for Prostate Cancer

Phase 1
Recruiting
Research Sponsored by Rashmi Verma, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of treatment initiation to psa progression (as defined by prostate cancer working group 2 [pcwg2]), an average of up to 4 years
Awards & highlights

Study Summary

This trial is testing the safety and side effects of a chemotherapy drug, cyclophosphamide, given with a corticosteroid drug, dexamethasone, to treat patients with castration resistant prostate cancer that has spread to other parts of the body.

Who is the study for?
This trial is for adult men with advanced prostate cancer that has spread and resisted castration treatment. They must understand the study, follow its schedule, have certain blood and organ function levels within set limits, and have tried at least two prior treatments including one targeting hormones.Check my eligibility
What is being tested?
The safety and side effects of combining cyclophosphamide (a chemotherapy drug) with dexamethasone (a corticosteroid) are being tested to see if they effectively treat metastatic castration-resistant prostate cancer with fewer side effects when given in low daily doses.See study design
What are the potential side effects?
Potential side effects may include nausea, hair loss, mouth sores from cyclophosphamide; while dexamethasone might cause increased appetite, mood changes, trouble sleeping. Side effects vary by individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of treatment initiation to psa progression (as defined by prostate cancer working group 2 [pcwg2]), an average of up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of treatment initiation to psa progression (as defined by prostate cancer working group 2 [pcwg2]), an average of up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility
Incidence of adverse events
Secondary outcome measures
Time to no longer clinical benefit (NLCB)
Prostate-Specific Antigen
Time to radiographic progression free survival (rPFS)
+1 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Diarrhoea
31%
Hypokalaemia
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Platelet count decreased
23%
Dizziness
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Tachypnoea
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Agitation
15%
Alanine aminotransferase increased
15%
Chills
15%
Hypomagnesaemia
15%
Thrombocytopenia
15%
Dyspnoea
15%
Sinus tachycardia
15%
Dysphagia
12%
Covid-19
12%
Aspartate aminotransferase increased
12%
Hyperglycaemia
12%
Hypoxia
12%
Abdominal pain
12%
Malaise
12%
Vomiting
12%
Hypertension
12%
Pain
12%
Myalgia
12%
Arthralgia
12%
Peripheral sensory neuropathy
8%
Aphasia
8%
Muscular weakness
8%
Gait disturbance
8%
Blood creatinine increased
8%
Lymphocyte count decreased
8%
Dysuria
8%
Sepsis
8%
Pancytopenia
8%
Oral candidiasis
8%
Urinary tract infection
8%
Hyperhidrosis
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Asthenia
4%
Embolism
4%
Respiratory failure
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Febrile neutropenia
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (cyclophosphamide, dexamethasone)Experimental Treatment2 Interventions
Patients receive cyclophosphamide PO QD and dexamethasone PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Rashmi Verma, MDLead Sponsor
National Cancer Institute (NCI)NIH
13,742 Previous Clinical Trials
40,957,758 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,005 Patients Enrolled for Prostate Cancer

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05479578 — Phase 1
Prostate Cancer Research Study Groups: Treatment (cyclophosphamide, dexamethasone)
Prostate Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05479578 — Phase 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05479578 — Phase 1
~4 spots leftby May 2025