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Cyclophosphamide for Prostate Cancer

University of California Davis Comprehensive Cancer Center, Sacramento, CA
Prostate Cancer+2 More ConditionsCyclophosphamide - Drug
Eligibility
18+
Male

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.

Eligible Conditions
  • Castration-resistant Prostate Cancer
  • Stage IVB Prostate Cancer
  • Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

1
Cyclophosphamide
1
Docetaxel
1
Ribociclib

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: From date of treatment initiation to PSA progression (as defined by Prostate Cancer Working Group 2 [PCWG2]), an average of up to 4 years

Year 4
Prostate-Specific Antigen
Year 4
Prostate-Specific Antigen
Year 4
Time to radiographic progression free survival (rPFS)
Year 4
Feasibility
Incidence of adverse events
Time to no longer clinical benefit (NLCB)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Cyclophosphamide
1
Docetaxel
1
Ribociclib

Side Effects for

Saline
47%Anemia
41%Nausea
31%Lymphocyte count decreased
28%Fatigue
28%Neutrophil count decreased
28%White blood cell decreased
13%Headache
13%Hypoatremia
13%Platelet count decreased
13%Constipation
13%Paresthesia
9%Cough
9%Alanine aminotransferase increased
9%Hypocalcemia
9%Hypokalemia
9%Myalgia
9%Vomiting
9%Hypoalbuminemia
6%Febrile neutropenia
6%Hypernatremia
6%Mucositis oral
6%Pain
6%Chills
6%Dyspnea
6%Edema Limbs
6%Flank Pain
6%Insomnia
3%Gastritis
3%Fibrinogen decreased
3%Depression
3%Hypomagnesemia
3%Hypotension
3%Non-cardiac chest pain
3%Pain in extremity
3%Palpitations
3%Pruritus
3%Sore Throat
3%Vaginal Infection
3%Wheezing
3%Blurred Vision
3%MRSA positive infection in toe
3%Alkaline phosphatase increased
3%Blood bilirubin increased
3%Allergic rhinitis
3%Anorexia
3%Lung Infection
3%Arthralgia
3%Dermatitis
3%Creatinine increased
3%Diarrhea
3%Esophageal Spasms
3%Hemorrhoids
3%Hyperglycemia
3%Lip Infection
3%Muscle weakness upper limb
3%Rash maculo-papular
3%Urinary Frequency
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT01205503) in the Saline ARM group. Side effects include: Anemia with 47%, Nausea with 41%, Lymphocyte count decreased with 31%, Fatigue with 28%, Neutrophil count decreased with 28%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment (cyclophosphamide, dexamethasone)
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Cyclophosphamide · No Placebo Group · Phase 1

Treatment (cyclophosphamide, dexamethasone)Experimental Group · 2 Interventions: Dexamethasone, Cyclophosphamide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2420
Cyclophosphamide
1995
Completed Phase 3
~3920

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of treatment initiation to psa progression (as defined by prostate cancer working group 2 [pcwg2]), an average of up to 4 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,386 Total Patients Enrolled
544 Trials studying Prostate Cancer
503,656 Patients Enrolled for Prostate Cancer
Rashmi Verma, MDLead Sponsor

Eligibility Criteria

Age 18+ · Male Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 more months.
References

Frequently Asked Questions

Has Cyclophosphamide been cleared by the FDA?

"Cyclophosphamide's lack of extensive clinical data only warrants a score of 1 in terms of safety." - Anonymous Online Contributor

Unverified Answer

Are new patients being signed up for this treatment study?

"The listed clinical trial on clinicaltrials.gov is actively searching for participants. The study was originally posted on 6/29/2022 and was last edited on 10/8/2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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