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Mitotic Inhibitor

Docetaxel + Radium 223 for Prostate Cancer

Phase 1

Waitlist Available

Led By Paul Mathew, MD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

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

Must have

Documented metastatic castration resistant disease with PSA progression, radiographic progression, or both, despite medical or surgical castration

Estimated glomerular filtration rate (GFR) > 30mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 years

Awards & highlights

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.

Who is the study for?

This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy. They must have a good level of blood cells, no severe liver issues, and at least two bone metastases. Men should be on ongoing castration treatment and agree to use birth control if applicable. Those with certain lung or liver metastases, neuroendocrine differentiation, severe neuropathy, other cancers needing treatment, brain metastases or bad reactions to docetaxel can't join.Check my eligibility

What is being tested?

The study tests the safest high dose of Radium-223 combined with split doses of Docetaxel in men with advanced prostate cancer. It aims to find the best dose for future patients by starting low and gradually increasing it across participants until they reach a limit due to side effects.See study design

What are the potential side effects?

Possible side effects include those common to chemotherapy like fatigue, nausea, hair loss; specific ones from Docetaxel such as fluid retention; and from Radium-223 like diarrhea and bone pain. Blood cell counts may drop leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is spreading despite treatments to lower testosterone.

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My kidney function is normal or only mildly reduced.

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I am 18 years old or older.

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I am currently undergoing hormone therapy for cancer.

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My prostate cancer was confirmed by a lab test.

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I have two or more bone metastases confirmed by a bone scan.

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I can care for myself and am up and about more than 50% of my waking hours.

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I am approved to receive docetaxel chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 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

Incidence of Dose Limiting Toxicities (DLT)

Secondary outcome measures

Efficacy, assessed as non-progression/progression rate according to prostate cancer working group (PCWG2) criteria

Overall Survival

Progression Free Survival (PFS)

+5 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

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%

Neurotoxicity

13%

Alanine aminotransferase increased

13%

Cough

13%

Vomting

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose expansionExperimental Treatment2 Interventions

If the maximum tolerated dose (MTD) of docetaxel is found in arm 1, this dose level will be expanded to include an additional 25 subjects to confirm the safety and explore the preliminary anti-cancer effect. If the MTD is not identified, the study will be stopped and the expansion cohort will not be accrued.

Group II: Dose escalationExperimental Treatment2 Interventions

There are four dose cohorts (1, 1a, 2, 2a) in this arm and two dose levels of docetaxel (40mg/m^2 [level 1] and 50mg/m^2 [level 2]). Dosing of Radium 223 remains the same in all cohorts (55 KBq/kg given every 28 days for 6 cycles). Maximum tolerated dose (MTD) of docetaxel will be assessed. MTD is defined as the highest dose-level, among those tested, associated with a rate of less than a 33% dose limiting toxicity (DLT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

Radium 223

2014

Completed Phase 2

~20

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor

255 Previous Clinical Trials

255,215 Total Patients Enrolled

BayerIndustry Sponsor

2,239 Previous Clinical Trials

25,332,685 Total Patients Enrolled

39 Trials studying Prostate Cancer

25,919 Patients Enrolled for Prostate Cancer

Lahey ClinicOTHER

72 Previous Clinical Trials

245,202 Total Patients Enrolled

2 Trials studying Prostate Cancer

5,052 Patients Enrolled for Prostate Cancer

Media Library

Docetaxel (Mitotic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03737370 — Phase 1

Prostate Cancer Research Study Groups: Dose expansion, Dose escalation

Prostate Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT03737370 — Phase 1

Docetaxel (Mitotic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03737370 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI