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New treatment option for Prostate Cancer Metastatic
Official title Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
ClinicalTrials.gov ID: NCT03833921
What this study is testing
What is Abiraterone Acetate?
Abiraterone Acetate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer metastatic.
Also referred to as Zytiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. All patients must have metastatic...
- Patients must have radiographic assessments of all disease including bone scan (or PET scan) within 42 days prior to registration. All disease will...
- Patients must have had no more than 42 days of prior castration (medical or surgical) for metastatic prostate cancer prior to starting abiraterone...
- Patients may have received prior ADT - neoadjuvant and/or adjuvant setting only - but it must not have lasted for more than 36 months. Single or...
- Patients who are deemed to have high-risk or extensive metastatic, hormone sensitive prostate cancer (mHSPC) per "clinical judgment" of the treating...
You likely can't join if
- Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs...
- Patients must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or...
- Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in...
- Patients must not have New York Heart Association Class III or IV heart failure at the time of screening. Patients must not have any thromboembolic...
- Patients with a known history of primary and secondary adrenal insufficiency are not eligible.
- Patients must not be known to have hypersensitivity to abiraterone or to LHRH agonist/antagonist.
See the full eligibility criteria
Who can join
- All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. All patients must have metastatic disease as evidenced by soft tissue and/or bony metastases prior to...
- Patients must have radiographic assessments of all disease including bone scan (or PET scan) within 42 days prior to registration. All disease will be assessed and documented on the appropriate CRF.
- Patients must have had no more than 42 days of prior castration (medical or surgical) for metastatic prostate cancer prior to starting abiraterone. The start date of medical castration is considered the day the patient...
- Patients may have received prior ADT - neoadjuvant and/or adjuvant setting only - but it must not have lasted for more than 36 months. Single or combination therapy allowed. At least 6 months must have elapsed since...
- Patients who are deemed to have high-risk or extensive metastatic, hormone sensitive prostate cancer (mHSPC) per "clinical judgment" of the treating physician are eligible for enrollment if the participants are...
- Patients may have received prior surgery. For all major surgeries, at least 14 days must have elapsed since completion and patient must have recovered from all major side effects of surgery per investigator's assessment.
- Patients may have received or plan to receive concurrent bone targeting agents that do not have an effect on PSA (e.g. denosumab or bisphosphonate).
- Patients must have no plans to receive any other experimental therapy while on the protocol treatment. Previous experimental therapy must have been completed at least 28 days prior to registration.
- Patients must have a complete physical examination and medical history within 28 days prior to registration.
- Patients must have a PSA ≥ 10 ng/mL obtained within 90 days prior to registration.
- Patients must have a QTc interval \< 461 msec on the 12 lead ECG within 42 days prior to registration. Patients with asymptomatic or incidental bundle branch blocks may have QTc measured by a cardiologist or standard...
- Patients must have adequate hepatic function, within 28 days prior to registration, as evidenced by: bilirubin ≤ 2 x institutional upper limit of normal (ULN), and SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤...
- Patients must have adequate renal function, within 28 days prior to registration, as evidenced by calculated creatinine clearance ≥ 40 mL/min using a serum creatinine or by 24-hour urine creatinine (using Cockroft-Gault...
- Patients must have adequate hematologic function, within 28 days prior to registration as evidenced by:
- leukocytes ≥ 3,000/mcL,
- absolute neutrophil count (ANC) ≥ 1,500/mcL,
- hemoglobin ≥ 9 g/dL, and
- platelets ≥ 100,000/mcL.
- Patients must have a Zubrod performance status of 0-2. Zubrod performance status 3 will be 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 patient is currently in complete...
- Patients must be ≥ 18 years of age.
- Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines...
What rules you out
- Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. But, if brain imaging...
- Patients must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
- Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed. At least 2 years must...
- Patients must not have New York Heart Association Class III or IV heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction, or serious...
- Patients with a known history of primary and secondary adrenal insufficiency are not eligible.
- Patients must not be known to have hypersensitivity to abiraterone or to LHRH agonist/antagonist.
- Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of abiraterone, including difficulty swallowing oral medications per investigator's...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.