Hormone + Radiation Therapy with TAK-700 for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+171 other locations

Overseen by Dror Michaelson, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer. PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.

Research Team

Dror Michaelson, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Men aged 18+ with high-risk prostate cancer, who may have started hormone therapy within the last 50 days but haven't had certain treatments like chemotherapy for prostate cancer. They should not have other active cancers or serious heart, liver, or kidney diseases and must be willing to use contraception.

Inclusion Criteria

Agree to completely abstain from intercourse.

My recent scans show no cancer spread to distant parts of my body.

My bone scan was unclear, but X-rays showed no cancer spread.

Exclusion Criteria

Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.

Q-wave infarction, unless identified 6 or more months prior to screening

I have a stomach or intestine condition that affects how I absorb pills.

Treatment Details

Interventions

• Bicalutamide (Anti-androgen)
• Buserelin (GnRH agonist)
• Flutamide (Anti-androgen)
• Goserelin acetate (GnRH agonist)
• Leuprolide acetate (GnRH agonist)
• Radiation therapy (Radiation)
• Steroid 17alpha-monooxygenase TAK-700 (Corticosteroid)

Trial Overview This phase III trial is testing if adding TAK-700 to standard hormone therapy and radiation helps treat high-risk prostate cancer better. It also looks at how these treatments affect patients' quality of life over time.

Participant Groups

Group I: TAK-700 + ADT + RT Experimental Treatment 4 Interventions

TAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years.

Group II: ADT + RT Active Control 3 Interventions

Standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT.

Bicalutamide is already approved in Japan, Canada for the following indications:

Approved in Japan as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in Canada as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

Dr. Gita Suneja

Radiation Therapy Oncology Group

Chief Medical Officer

MD from University of Utah School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School