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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
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 weeks3 visits
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
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
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 moreSide effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
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%
Hyponatraemia
19%
Hypogammaglobulinaemia
19%
Tachypnoea
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Agitation
15%
Chills
15%
Hypomagnesaemia
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Dyspnoea
15%
Sinus tachycardia
15%
Dysphagia
12%
Covid-19
12%
Aspartate aminotransferase increased
12%
Hyperglycaemia
12%
Abdominal pain
12%
Hypoxia
12%
Vomiting
12%
Malaise
12%
Hypertension
12%
Pain
12%
Myalgia
12%
Arthralgia
12%
Peripheral sensory neuropathy
8%
Gait disturbance
8%
Blood creatinine increased
8%
Lymphocyte count decreased
8%
Dysuria
8%
Pancytopenia
8%
Sepsis
8%
Hyperhidrosis
8%
Oral candidiasis
8%
Urinary tract infection
8%
Aphasia
8%
Muscular weakness
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
~2640
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Rashmi Verma, MDLead Sponsor
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,389 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,005 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a severe infection in the last 28 days that would make it unsafe for me to join the trial.I am 18 years old or older.My scans show at least one cancer spread to another part of my body.I can take care of myself but may not be able to do heavy physical work.I haven't had systemic therapy for prostate cancer in the last 2 weeks.My prostate cancer has worsened after at least 2 treatments, including drugs like abiraterone or enzalutamide.I have a blockage in my urinary flow that hasn't been treated.My prostate cancer was confirmed by a lab test.My PSA levels have significantly increased after my last treatment.My kidneys are functioning well enough to clear waste.My blood clotting tests are within normal limits, or I've been on a stable dose of blood thinners for at least a week.I have had treatment for my BRCA/HR mutation or MSI cancer.I have no active cancer requiring treatment, except for skin cancer or the cancer this study is about.I have Hep B under control or Hep C, with or without treatment.I am a male and will use effective birth control and a barrier method during and 90 days after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclophosphamide, dexamethasone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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