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

• Status: Active, not recruiting
• Trial end date: 2029-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); NRG Oncology
• Treatments: Bicalutamide; Buserelin; Deslorelin; Flutamide; Goserelin; Leuprolide; Triptorelin Pamoate

Criteria

DISEASE CHARACTERISTICS:

• 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 (risk group):

• 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

• Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) agonist or antiandrogen 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., diethyl- stilbestrol [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

• Clinically negative lymph nodes as established by imaging (abdominal and/or pelvic CT or abdominal and/or pelvic 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

• Equivocal bone scan findings are allowed if plain films are negative for metastasis

• No definite evidence of metastatic disease

• 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 radiotherapy (EBRT) only

PATIENT CHARACTERISTICS:

• Height, weight, Zubrod performance status 0-1

• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3

• Platelets ≥ 100,000 cells/mm^3

• Hemoglobin ≥ 8.0 g/dL (The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)

• Serum creatinine < 2.0 mg/dL

• Creatinine clearance > 40 mL/minute

• Bilirubin < 1.5 x upper limit of normal (ULN)

• Alanine aminotranserase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN

• No PSA > 150 ng/mL

• Screening calculated ejection fraction ≥ ULN by multiple-gated acquisition (MUGA) scan or by echocardiogram

• 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.

• Patients, even if surgically sterilized (i.e., status post vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and for 4 months (120 days) after the last dose of study drug

• No prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years

• No known hypersensitivity to TAK-700 or related compounds

• No history of adrenal insufficiency

• No history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (NCI CTCAE, version 4.02) thromboembolic events (e.g., 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

• No New York Heart Association Class III or IV heart failure

• No ECG abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening, or corrected QT (QTc) interval > 460 msec

• No prior allergic reaction to the drugs involved in this protocol

• No Cushing syndrome

• No severe chronic renal disease or chronic liver disease

• No uncontrolled hypertension despite appropriate medical therapy within 21 days prior to registration (blood pressure of greater than 150 mm Hg systolic and 90 mm Hg diastolic at 2 separate measurements no more than 60 minutes apart during screening visit)

• No serious infection within 14 days prior to registration

• No uncontrolled nausea, vomiting, or diarrhea (CTCAE grade ≥ 3) despite appropriate medical therapy at the time of registration

• No known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Prior testosterone administration is allowed if last administered at least 90 days prior to registration

• No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason

• No prior systemic chemotherapy for prostate cancer

• Prior chemotherapy for a different cancer is allowed

• No prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields

• No previous hormonal therapy for > 50 days

• No chronic treatment with glucocorticoids within one year

• No major surgery within 14 days prior to registration

• No other investigational agent

• No other anticancer therapy

• No concurrent hormonal therapies including estrogens or herbal products

• No concurrent ketoconazole or aminoglutethimide

• No chronic use of systemic corticosteroids, such as oral prednisone