Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer

NCT01546987 | Completed Phase 3 Results DMC

• 3 other identifiers: RTOG 1115CDR0000727326NCI-2012-00700
• Study Type: interventional
• Target: 239
• Locations: 2 countries
• Sites: 172

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIA prostate cancer; stage IIB prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol)

  Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

Secondary Outcomes (20)

• Percentage of Patients Alive [Overall Survival] (Primary Endpoint of Original Protocol)

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

• Percentage of Participants With Grade 3 or Higher Adverse Events

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

• Percentage of Participants With Local Progression

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates reported.

• Percentage of Participants With Distant Metastases

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

• Percentage of Participants With General Clinical Treatment Failure

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

Other Outcomes (2)

• Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Ethnicity

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

• Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) by Race

  From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

Study Arms (2)

ADT + RT

ACTIVE COMPARATOR

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.

Drug: GnRH agonist; Drug: Anti-androgen; Radiation: Radiation therapy

TAK-700 + ADT + RT

EXPERIMENTAL

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.

Drug: GnRH agonist; Drug: Anti-androgen; Drug: TAK-700; Radiation: Radiation therapy

Interventions

GnRH agonist DRUG

LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable).

Also known as: LHRH analog, leuprolide, goserelin, buserelin, triptorelin, Gonadotropin-releasing hormone (GnRH) Agonist, LHRH agonist

ADT + RT; TAK-700 + ADT + RT

Anti-androgen DRUG

Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).

Also known as: flutamide, bicalutamide, androgen suppression

ADT + RT; TAK-700 + ADT + RT

TAK-700 DRUG

300 mg twice daily (BID) (600 mg per day) orally, continuously for 2 years starting with ADT.

TAK-700 + ADT + RT

Radiation therapy RADIATION

Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy.

ADT + RT; TAK-700 + ADT + RT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations:
• Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage
• GS ≥ 8, PSA \< 20 ng/mL, T stage ≥ T2
• GS ≥ 8, PSA ≥ 20-150 ng/mL, any T stage
• GS ≥ 7, PSA ≥ 20-150 ng/mL, any T stage
• History/physical examination within 60 days prior to registration.
• Clinically negative lymph nodes as established by imaging \[abdominal and/or pelvic computerized tomography (CT) or abdominal and/or pelvic magnetic resonance imaging (MRI)\], nodal sampling, or dissection within 90 days prior to registration.
• Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are \< 2.0 cm.
• No distant metastases (M0) on bone scan within 90 days prior to registration (18F-Na bone scan is an acceptable substitute).
• Equivocal bone scan findings are allowed if plain films are negative for metastasis.
• Baseline serum prostate-specific antigen (PSA) value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) or anti-androgen therapy, within 180 days of randomization.
• Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy), may have been started prior to registration, provided that registration is within 50 days of beginning ADT. Please note: If the patient has started ADT he will not be eligible to participate in the quality of life component of this study.
• Prior testosterone administration is allowed if last administered at least 90 days prior to registration.
• Zubrod Performance Status 0-1 within 21 days prior to registration
• Age ≥ 18

You may not qualify if:

• PSA \> 150
• Definite evidence of metastatic disease.
• Pathologically positive lymph nodes or nodes \> 2.0 cm on imaging.
• Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason.
• Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years.
• Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed).
• Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.
• Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume \<60 cc, American Urological Association (AUA) score ≤15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive external beam radiation therapy \[EBRT\] only).
• Previous hormonal therapy for \> 50 days.
• Known hypersensitivity to TAK-700 or related compounds
• A history of adrenal insufficiency
• History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \> 2 \[NCI CTCAE, version 4.02\] (U.S. Department of Health and Human Services, National Institutes of Health National Cancer Institute, 2009), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to registration. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
• New York Heart Association Class III or IV heart failure.
• ECG abnormalities of:
• Q-wave infarction, unless identified 6 or more months prior to screening

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (172)

The Kirklin Clinic at Acton Road

Birmingham, Alabama, 35243, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology-Deer Valley Center

Phoenix, Arizona, 85027, United States

Location

Arizona Oncology Services Foundation

Scottsdale, Arizona, 85260, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

Veterans Administration Long Beach Medical Center

Long Beach, California, 90822, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

Sutter General Hospital

Sacramento, California, 95816, United States

Location

University of California At San Diego

San Diego, California, 92103, United States

Location

UCSF-Mount Zion

San Francisco, California, 94115, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States

Location

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, 95687, United States

Location

Sutter Solano Medical Center

Vallejo, California, 94589, United States

Location

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Poudre Valley Radiation Oncology

Fort Collins, Colorado, 80528, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

William Backus Hospital

Norwich, Connecticut, 06360, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Saint Joseph's-Candler Health System

Savannah, Georgia, 31405, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Idaho Urologic Institute PA

Meridian, Idaho, 83642, United States

Location

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Hines Veterans Administration Hospital

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Radiation Oncology Associates PC

Fort Wayne, Indiana, 46804, United States

Location

Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kansas City Cancer Centers-Southwest

Overland Park, Kansas, 66210, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Touro Infirmary

New Orleans, Louisiana, 70115, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074, United States

Location

Saint Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Saint Anne's Hospital

Fall River, Massachusetts, 02721, United States

Location

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

Milford, Massachusetts, 01757, United States

Location

North Shore Medical Center Cancer Center

Peabody, Massachusetts, 01960, United States

Location

Dana-Farber/Brigham and Women's Cancer Center at South Shore

South Weymouth, Massachusetts, 02190, United States

Location

Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

McLaren-Flint

Flint, Michigan, 48532, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Great Lakes Cancer Institute-Lapeer Campus

Lapeer, Michigan, 48446, United States

Location

McLaren Cancer Institute-Owosso

Owosso, Michigan, 48867, United States

Location

Northern Michigan Regional Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital - Troy

Troy, Michigan, 48098, United States

Location

Sanford Clinic North-Bemidgi

Bemidji, Minnesota, 56601, United States

Location

Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States

Location

Siteman Cancer Center - Saint Peters

City of Saint Peters, Missouri, 63376, United States

Location

Kansas City Cancer Center - South

Kansas City, Missouri, 64131, United States

Location

Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States

Location

Kansas City Cancer Center-Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Barnes-Jewish West County Hospital

St Louis, Missouri, 63141, United States

Location

Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Concord Hospital

Concord, New Hampshire, 03301, United States

Location

Exeter Hospital

Exeter, New Hampshire, 03833, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MD Anderson Cancer Center at Cooper-Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Medical Center-Fargo

Fargo, North Dakota, 58122, United States

Location

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, 44304, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Summa Barberton Hospital

Barberton, Ohio, 44203, United States

Location

Geaugra Hospital

Chardon, Ohio, 44024, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States

Location

Summa Health Center at Lake Medina

Medina, Ohio, 44256, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Southwest General Health Center Ireland Cancer Center

Middleburg Heights, Ohio, 44130, United States

Location

UHHS-Chagrin Highlands Medical Center

Orange, Ohio, 44122, United States

Location

Robinson Radiation Oncology

Ravenna, Ohio, 44266, United States

Location

Ireland Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

Flower Hospital

Sylvania, Ohio, 43560, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States

Location

Rogue Valley Medical Center

Medford, Oregon, 97504, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

The Regional Cancer Center

Erie, Pennsylvania, 16505, United States

Location

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Cherry Tree Cancer Center

Hanover, Pennsylvania, 17331, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

WellSpan Health-York Hospital

York, Pennsylvania, 17405, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Texas Oncology PA - Bedford

Bedford, Texas, 76022, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The Klabzuba Cancer Center

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0565, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States

Location

Texas Cancer Center-Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, 77479, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States

Location

Dixie Medical Center Regional Cancer Center

St. George, Utah, 84770, United States

Location

Sentara Cancer Institute at Sentara CarePlex Hospital

Hampton, Virginia, 23666, United States

Location

Sentara Hospitals

Norfolk, Virginia, 23507, United States

Location

Oncology and Hematology Associates of Southwest Virginia

Roanoke, Virginia, 24014, United States

Location

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States

Location

Saint Francis Hospital

Federal Way, Washington, 98003, United States

Location

Virginia Mason CCOP

Seattle, Washington, 98101, United States

Location

Appleton Medical Center

Appleton, Wisconsin, 54911, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Gundersen Lutheran

La Crosse, Wisconsin, 54601, United States

Location

Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Columbia Saint Mary's Hospital - Ozaukee

Mequon, Wisconsin, 53097, United States

Location

Columbia Saint Mary's Water Tower Medical Commons

Milwaukee, Wisconsin, 53211, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

Wheaton Franciscan Cancer Care - All Saints

Racine, Wisconsin, 53405, United States

Location

Door County Cancer Center

Sturgeon Bay, Wisconsin, 54235-1495, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BCCA-Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute-General Division

Ottawa, Ontario, K1H 1C4, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone; Leuprolide; Goserelin; Buserelin; Triptorelin Pamoate; Androgen Antagonists; Flutamide; bicalutamide; orteronel; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics

Limitations and Caveats

This study closed to accrual early at 238 participants out of 900 planned due to discontinuation of support from the industry partner (Takeda/Millenium) for further development of TAK-700 in prostate cancer. The study endpoints and statistical considerations were revised to take the smaller sample size into account. The revised protocol contains both the original and revised statistical sections.

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

215-574-3208

Study Officials

• M. Dror Michaelson, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2012
• First Posted: March 7, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2021
• Study Completion: September 4, 2025
• Last Updated: March 6, 2026
• Results First Posted: April 18, 2023

Record last verified: 2025-09

Locations

CA (7); US (165)