Docetaxel + Radium 223 for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byPaul Mathew, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Tufts Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine the maximum safe dose of Ra-223 in combination with fractionated (split doses) docetaxel when given to subjects and to determine the best administering dose. The study will look at side effects that may happen while taking the combination treatment. A total of approximately 18 subjects will take part in the dose escalation part of the study and an additional 25 subjects will participate in the expansion cohort. This study will be conducted across four centers in the United States.

Eligibility Criteria

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.

Inclusion Criteria

My prostate cancer is spreading despite treatments to lower testosterone.

Hemoglobin > 10 g/dL

Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures.

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Exclusion Criteria

I have moderate to severe nerve damage in my hands or feet.

I am currently being treated for another type of cancer.

I haven't taken antiandrogen therapy in the last 4 weeks, or if I did, it didn't work.

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Treatment Details

Interventions

Docetaxel (Mitotic Inhibitor)
Radium 223 (Radioactive Agent)

Trial OverviewThe 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.

Participant Groups

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).

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Taxotere for: