Docetaxel for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lahey Hospital & Medical Center, Boston, MAProstate CancerDocetaxel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment combining two drugs, to see what the maximum safe dose is, and what side effects may occur. A total of 18-43 people will take part across four US centers.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 25 years

Year 25
Efficacy, assessed as non-progression/progression rate according to prostate cancer working group (PCWG2) criteria
Response to treatment, as assessed by prostate-specific antigen (PSA) Kinetics and Objective Responses
Satisfaction, as assessed by Quality of Life Questionnaires
Up to 25 years
Overall Survival
Progression Free Survival (PFS)
Time to Treatment Failure (TTTF)
Up to 28 weeks
Proportion of Randomized Subjects to Complete Combination Therapy on Schedule per Protocol
Response to Treatment, as assessed by Bone Bio-marker Outcomes
Up to 29 Days
Incidence of Dose Limiting Toxicities (DLT)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Oedema peripheral
16%Diarrhoea
16%Hypophagia
13%Alanine aminotransferase increased
13%Neurotoxicity
13%Cough
13%Vomting
9%Aspartate aminotransferase increased
9%Headache
9%Musculoskeletal pain
9%Chest discomfort
9%Rash
9%Pigmentation disorder
9%Nausea
9%Bone marrow failure
9%Anaemia
6%Transaminases increased
6%Insomnia
6%Nasopharyngitis
6%Paronychia
6%Flushing
6%Face oedema
6%Constipation
6%Mouth ulceration
6%Thrombocytopenia
3%Cataract
3%Infection
3%Upper respiratory tract infection
3%Completed suicide
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

2 Treatment Groups

Dose expansion
1 of 2
Dose escalation
1 of 2

Experimental Treatment

25 Total Participants · 2 Treatment Groups

Primary Treatment: Docetaxel · No Placebo Group · Phase 1

Dose expansionExperimental Group · 2 Interventions: Radium 223, Docetaxel · Intervention Types: Radiation, Drug
Dose escalationExperimental Group · 2 Interventions: Radium 223, Docetaxel · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radium 223
2014
Completed Phase 2
~20
Docetaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 25 years

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterOTHER
290 Previous Clinical Trials
286,114 Total Patients Enrolled
10 Trials studying Prostate Cancer
4,639 Patients Enrolled for Prostate Cancer
Henry Ford HospitalOTHER
23 Previous Clinical Trials
6,076 Total Patients Enrolled
Lahey ClinicOTHER
70 Previous Clinical Trials
245,013 Total Patients Enrolled
2 Trials studying Prostate Cancer
5,052 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,159 Previous Clinical Trials
23,877,513 Total Patients Enrolled
36 Trials studying Prostate Cancer
25,162 Patients Enrolled for Prostate Cancer
Tufts Medical CenterLead Sponsor
240 Previous Clinical Trials
245,236 Total Patients Enrolled
Paul Mathew, MDPrincipal InvestigatorTufts Medical Center
4 Previous Clinical Trials
74 Total Patients Enrolled
3 Trials studying Prostate Cancer
57 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · All Participants · 16 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten criterion: You are able to receive docetaxel chemotherapy as a treatment option.
References

Frequently Asked Questions

What other experimental examinations have been conducted utilizing Docetaxel?

"Currently, there are 320 publicly listed Docetaxel trials with 126 at phase 3. Most of these studies originate from Fuzhou in Fujian province; however, clinicaltrials.gov lists 22389 sites across the world offering treatment with this drug." - Anonymous Online Contributor

Unverified Answer

What health risks has Docetaxel been linked to in patients?

"Due to limited clinical data, Docetaxel is rated a 1 on the safety scale created by our team at Power; this rating reflects that it is currently in the first phase of evaluation." - Anonymous Online Contributor

Unverified Answer

How many individuals have been recruited to participate in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this trial, which was first published on January 30th 2018, is actively searching for participants. 25 individuals from 4 different sites need to be recruited." - Anonymous Online Contributor

Unverified Answer

Are people being accepted for participation in this experiment at the present time?

"Affirmative, according to clinicaltrials.gov's records this experiment is currently enrolling volunteers. It was first announced on the 30th of January 2018 and revised most recently in February 2022. The project requires 25 individuals signing up at four distinct locations." - Anonymous Online Contributor

Unverified Answer

For what maladies is Docetaxel regularly prescribed?

"Docetaxel can be utilized to combat malignant neoplasms, advance directives, and sarcoma." - 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.