SWOG clinical trial number

S1216

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer

100% Accrual

Accrual

100%

Closed

Phase

100% Accrual

Accrual

100%

Abbreviated Title

Metastatic Prostate Cancer, Phase III ADT+TAK-700 vs. ADT+Bicalutamide

Activated

03/01/2013

Closed

07/15/2017

Participants

NCORP, Members, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY, Affiliates

Research committees

Genitourinary Cancer

Treatment

Bicalutamide Leuprolide Acetate Goserelin Acetate TAK-700

Eligibility Criteria Expand/Collapse

Pts must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Pts
must have metastatic disease as evidenced by soft tissue and/or bony mets prior to initiation of androgen deprivation
therapy. Pts must have radiographic assessments of all disease including bone scan (or PET) within 42 days prior to registration. Pts with brain mets are not eligible. Pts deemed high risk or extensive metastatic HSPC eligible if unsuitable or have declined docetaxel. Prior androgen deprivation therapy (ADT) - neoadjuvant and/or adjuvant setting only - of no more than 36 months is allowed. At least 6 mo since completion of ADT, and serum testosterone must be > 50 ng/mL (non-castrate levels) at the time of registration for early induction pts. Must not have received ketoconazole, aminoglutethimide, or abiraterone acetate. Must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. At least 2 yrs since last cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting. Prior surgery, and current/planned bone targeting agents are allowed. Pts must not have plans to receive experimental therapy or LHRH antagonists. Pts must have had no more than 30 days since prior castration (medical or surgical). Pts must have a PSA>/=2 ng/mL. Pts must have a DEXA bone scan within the past 2yrs. Pts must not have Grade III/IV heart failure at time of screening. Pts must not have any thromboembolic event, unstable angina pectoris, MI, or serious uncontrolled cardiac arrhythmia w/in 6 mo prior to registration. Pts must have the following w/in 28 days prior to registration: PE & Hx, QTc interval < 461 msec, ECHO/MUGA LVEF >50%, BP <160 mmHg systolic/<90 mmHg diastolic, bilirubin </= 2X IULN, AST/ALT </= 3X IULN (or 5X IULN, for liver mets), calculated creatinine >/= 40 mL/min, leukocytes >/= 3,000/mcL, ANC >/= 1,500/mcL, hemoglobin >/= 9 g/dL, and platelets >/= 100,000/mcL. Pts must not have HIV, Hep B/C, or any serious medical or psychiatric illness. Pts with a Hx of of primary and secondary adrenal insufficiency are not eligible. Pts must not have hypersensitivity to TAK-700, TAK-700 metabolites, bicalutamide, or LHRH agonists. Pts must be able to take oral medications. Pts must have PS=0-2; PS=3 allowed (if from bone pain only). No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the pt has been disease-free for 5 yrs. Pts must be 18 yrs of age or older. Pts must be offered the opportunity to participate in specimen banking for future use to include translational medicine studies outlined in Section 15.0.

Publication Information Expand/Collapse

Other Clinical Trials

S2312

SWOG Clinical Trial Number

A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature

Research Committee(s)

Genitourinary Cancer

Activated

09/03/2024

4% Accrual

Accrual

Open

Phase

S2210

SWOG Clinical Trial Number

S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"

Research Committee(s)

Genitourinary Cancer

Activated

08/14/2023

9% Accrual

Accrual

Open

Phase

S2200

SWOG Clinical Trial Number

S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2

Research Committee(s)

Genitourinary Cancer

Activated

09/19/2022

16% Accrual

Accrual

16%

Open

Phase

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer

Research committees

Treatment

Eligibility Criteria Expand/Collapse

Publication Information Expand/Collapse

2024

2023

2022

2021

2020

2018

2016

2014

Other Clinical Trials

A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature

S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"

S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2