Prostate CancerPhase 2NCT01254864
Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies
A Phase 2 study testing Abiraterone Acetate, Prednisone and Sunitinib in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body. This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being researched. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Abiraterone Acetate, Prednisone and Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2011to 7 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Male aged 18 years and above
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT or MRI.
- Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
- Surgically or medically castrated, with testosterone levels of </= 50 ng/dL (</= 2.0 nM). If the patient is being treated with LHRH agonists (patients who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.
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- If the patient received previous anti-androgen therapy, then they have shown progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (>/= 4 weeks since last flutamide, >/= 6 weeks since last bicalutamide or nilutamide). If progression is documented prior to this time interval, patients are eligible.
- Previous treatment with docetaxel is allowed. Patients must have recovered from any acute toxicity related to the treatment to be eligible.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1.
- Hemoglobin >/= 9.0 g/dL
- Platelet count >/= 100,000/microL
- Serum albumin >/= 3.5 g/dL
- Serum creatinine </= 1.5 x ULN or a calculated creatinine clearance >/= 60 mL/min
- Serum potassium >/= 3.5 mmol/L
- Serum sodium, magnesium, potassium, phosphate, and calcium >/= LLN (lower limit of normal)
- ANC value >/= 1,000/mm^3
- Liver function: i. Serum bilirubin </= 1.5 x ULN (except for patients with documented Gilbert's disease) ii. AST or ALT </= 2.5 x ULN
- Able to swallow the study drug whole as a tablet/capsule.
- Patients who have partners of childbearing potential (.e.g. female that has not been surgically sterilized or who are not amenorrheic for >/= 12 months) must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 13 weeks after last study drug administration.
- Concomitant Medications (i) Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (at least 5 days prior). (ii) Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia; (iii) Patient agrees to discontinue use of drugs primarily metabolized by CYP3A4 enzyme; (iv) Patient agrees to discontinue use of H2 Inhibitors or proton inhibitors prior to dasatinib administration.
Who cannot join
- Active infection (requiring oral or IV antibiotics) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily.
- Pathological finding consistent with small cell carcinoma of the prostate
- Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1. Patients who have received palliative radiation to a single site and recovered are eligible.
- No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.)
- Previously treated with ketoconazole (for prostate cancer) for greater than 7 consecutive days OR previously treated with any other -azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
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- Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
- Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
- Uncontrolled hypertension (systolic BP >/= 140 mmHg or diastolic BP >/= 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- Prolonged QTc interval on pre-entry electrocardiogram (>/= 450 msec)
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Known brain metastasis
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
- History of significant bleeding disorder unrelated to cancer, including: i) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) ii) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) iii) Ongoing or recent (</= 3 months) significant gastrointestinal bleeding
- Atrial fibrillation or other cardiac arrhythmia requiring digitalis
- Other malignancy, except non-melanoma skin cancer, with a >/= 30% probability of recurrence within 24 months
- Clinically significant pleural effusion as determined by the Principal Investigator.
- Administration of an investigational therapy for prostate cancer within 30 days of Cycle 1, Day 1
- Any condition which, in the opinion of the investigator, would preclude participation in this trial.
- Patients taking category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) i) quinidine, procainamide, disopyramide ii) amiodarone, sotalol, ibutilide, dofetilide iii) erythromycin, clarithromycin iv) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide v) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body.
This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being researched. Sunitinib malate is FDA-approved for the treatment of gastrointestinal tumors and renal cell carcinoma, and dasatinib is FDA approved and commercially available for certain types of leukemia. The use of these drugs in prostate cancer and in combination with abiraterone acetate and prednisone is investigational.
Up to 180 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Read the detailed description
The Study Drugs:
Abiraterone acetate is designed to block male hormones in the body that may cause prostate cancer to grow.
Prednisone is commonly given in combination with other drugs to patients with prostate cancer. In this study, it is being used in combination with abiraterone acetate in order to help prevent side effects that abiraterone acetate may cause.
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Dasatinib is designed to change the function of genes. By changing the function of these genes, it may prevent cancer from growing and spreading.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 4 tablets of abiraterone acetate by mouth every day. The tablets should be taken all at once, at least 1 hour before a meal or 2 hours after a meal. You will also take 1 tablet of prednisone by mouth 2 times each day. You will take both of these drugs throughout the entire study.
If the disease gets worse while you are taking abiraterone acetate and prednisone, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.
- If you are assigned to Group 1, you will start taking sunitinib malate. You will take 3 capsules by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone.
- If you are assigned to Group 2, you will start taking dasatinib. You will take 2 tablets by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone. Dasatinib tablets should be swallowed whole, with or without a meal. If you accidentally miss taking a dose of dasatinib, it may be taken within 12 hours later. If you vomit within 30 minutes of taking the tablets, that dose may be repeated. If you miss a dose due to side effects, the dose should not be replaced.
If the disease gets worse after you have been assigned to a group, and you are still eligible to continue taking the study drugs, you will "crossover" to the other group. If you were in Group 1, you would stop taking sunitinib malate and begin taking dasatinib. If you were in Group 2, you would stop taking dasatinib and begin taking sunitinib malate. No matter which group you crossover to, you will continue taking abiraterone acetate and prednisone.
Study Visits:
At each study visit, you will be asked about any other drugs you may be receiving and about any side effects you may be having.
Every 2 weeks during the first 12 weeks of taking abiraterone acetate and prednisone and during the first 3 cycles (9-12 weeks) of each new treatment combination, blood (about 1-2 tablespoons) will be collected to test your liver function.
Every 4 weeks, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 1-2 tablespoons) and urine will be collected for routine tests. Part of this blood will be used to measure your PSA and your levels of a specific marker of prostate cancer.
- You will be asked questions about how you are feeling and about any side effects you may have had since your last visit.
- You will be asked about any other drugs you may be taking.
- Your performance status will be recorded.
If the disease gets worse (or you change treatments) at any point in the study, the following tests and procedures will be performed:
- Blood (about 1-2 tablespoons) and urine will be collected for routine tests.
- You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease.
- You will have an ECG and an echocardiogram or a MUGA scan.
- You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease.
If your doctor thinks it is necessary:
°You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will be taken off study if the disease gets worse after crossover, if you experience intolerable side effects, or if the doctor thinks that it is in your best interest.
End of Treatment Visit:
After you stop receiving the study drugs for any reason, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your PSA level, your level of a specific marker of prostate cancer, and to check for a protein related to cancer.
- You will be asked questions about how you are feeling and about any side effects you may have had since your last visit.
- You will be asked about any other drugs you may be taking.
- Your performance status will be recorded.
- You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease.
Post-Treatment (Safety) Follow-Up Visit:
About 30 days after your last dose of study drugs, the following tests and procedures will be performed:
- You will have a physical exam, including a measurement of your vital signs.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- Your performance status will be recorded.
- You will be asked about any side effects you may have experienced since your last visit.
- You will be asked about any other drugs you may be taking.
Long-Term Follow-Up:
A member of the study staff will check up on you about every 6 months after your Post-Treatment (Safety) Follow-Up Visit. This will consist of a phone call, an e-mail, or a review of your medical and/or other records. If you are contacted by phone, the call will only last a few minutes.
After your End-of-Treatment visit, the study staff will contact you by phone, e-mail, or you will come in for a clinic visit. You will be asked about how you are feeling and any side effects you may have had. Each follow-up will take about 5 minutes. Follow-up will take place every 3 months for the first 2 years, every 6 months for the third year, and 1 time a year after that. The last follow-up will be about 5 years after the last patient is enrolled.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone Acetate, Prednisone, Sunitinib, Dasatinib
- Keywords
- Castrate resistant prostate cancer, Adenocarcinoma of the prostate, Sunitinib Malate, SUO11248, Sutent, BMS-354825, Sprycel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateDrug
Also called CB7630
1000 mg by mouth each day of a 28 day cycle.
PrednisoneDrug
5 mg by mouth twice daily of a 28 day cycle.
SunitinibDrug
Also called Sunitinib Malate, SUO11248, Sutent
37.5 mg by mouth daily for two weeks followed by a week of rest in a 28 day cycle.
DasatinibDrug
Also called BMS-354825, Sprycel
100 mg by mouth each day of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone Acetate + Prednisone (AP) | Experimental | Abiraterone Acetate at 1000 mg orally each day, given in combination with 5 mg of Prednisone orally twice daily. Receives: Drug: Abiraterone Acetate; Drug: Prednisone |
| Group 1: AP + Sunitinib | Experimental | AP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression. Receives: Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Sunitinib |
| Group 2: AP + Dasatinib | Experimental | AP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression. Receives: Drug: Abiraterone Acetate; Drug: Prednisone; Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure (TTF)
Time to treatment failure (TTF), defined as time from randomization (AP+S or AP+D) to progression per PCWG2 criteria or death.
Measured: Up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study start16 Mar 2011
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Janssen Scientific Affairs, LLC, Pfizer
- Responsible party
- Sponsor
- Investigators
- Paul Corn, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254864
- Sponsor's protocol ID
- 2010-0070
- Other IDs
- NCI-2011-00267
- Status last verified
- Jan 2025
- First submitted
- 3 Dec 2010
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sakellakis MJ, Hahn AW, Ramachandran S, Zhang M, Hoang A, Song JH, Liu J, Wang F, Basu HS, Sheperd P, Wang X, Frigo DE, Lin SH, Panaretakis T, Zhang J, Navone N, Troncoso P, Logothetis CJ, Titus MA. Characterization of prostate cancer adrenal metastases: dependence upon androgen receptor signaling and steroid hormones. Prostate Cancer Prostatic Dis. 2023 Dec;26(4):751-758. doi: 10.1038/s41391-022-00590-x. Epub 2022 Sep 13.
PubMed 36100698Boukovala M, Spetsieris N, Weldon JA, Tsikkinis A, Hoang A, Aparicio A, Tu SM, Araujo JC, Zurita AJ, Corn PG, Pagliaro L, Kim J, Wang J, Subudhi SK, Tannir NM, Logothetis CJ, Troncoso P, Wen S, Efstathiou E. A candidate androgen signalling signature predictive of response to abiraterone acetate in men with metastatic castration-resistant prostate cancer. Eur J Cancer. 2020 Mar;127:67-75. doi: 10.1016/j.ejca.2019.12.027. Epub 2020 Jan 24.
PubMed 31986451
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies
- ClinicalTrials.gov ID
- NCT01254864
- Acronym / sponsor ID
- 2010-0070
- Conditions
- Prostate Cancer
- Keywords
- Castrate resistant prostate cancer, Adenocarcinoma of the prostate, Sunitinib Malate, SUO11248, Sutent, BMS-354825, Sprycel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Janssen Scientific Affairs, LLC, Pfizer
- Study start
- 16 Mar 2011 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body.
This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being researched. Sunitinib malate is FDA-approved for the treatment of gastrointestinal tumors and renal cell carcinoma, and dasatinib is FDA approved and commercially available for certain types of leukemia. The use of these drugs in prostate cancer and in combination with abiraterone acetate and prednisone is investigational.
Up to 180 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Detailed description
The Study Drugs:
Abiraterone acetate is designed to block male hormones in the body that may cause prostate cancer to grow.
Prednisone is commonly given in combination with other drugs to patients with prostate cancer. In this study, it is being used in combination with abiraterone acetate in order to help prevent side effects that abiraterone acetate may cause.
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Dasatinib is designed to change the function of genes. By changing the function of these genes, it may prevent cancer from growing and spreading.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 4 tablets of abiraterone acetate by mouth every day. The tablets should be taken all at once, at least 1 hour before a meal or 2 hours after a meal. You will also take 1 tablet of prednisone by mouth 2 times each day. You will take both of these drugs throughout the entire study.
If the disease gets worse while you are taking abiraterone acetate and prednisone, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.
- If you are assigned to Group 1, you will start taking sunitinib malate. You will take 3 capsules by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone.
- If you are assigned to Group 2, you will start taking dasatinib. You will take 2 tablets by mouth 1 time each day, while continuing to take abiraterone acetate and prednisone. Dasatinib tablets should be swallowed whole, with or without a meal. If you accidentally miss taking a dose of dasatinib, it may be taken within 12 hours later. If you vomit within 30 minutes of taking the tablets, that dose may be repeated. If you miss a dose due to side effects, the dose should not be replaced.
If the disease gets worse after you have been assigned to a group, and you are still eligible to continue taking the study drugs, you will "crossover" to the other group. If you were in Group 1, you would stop taking sunitinib malate and begin taking dasatinib. If you were in Group 2, you would stop taking dasatinib and begin taking sunitinib malate. No matter which group you crossover to, you will continue taking abiraterone acetate and prednisone.
Study Visits:
At each study visit, you will be asked about any other drugs you may be receiving and about any side effects you may be having.
Every 2 weeks during the first 12 weeks of taking abiraterone acetate and prednisone and during the first 3 cycles (9-12 weeks) of each new treatment combination, blood (about 1-2 tablespoons) will be collected to test your liver function.
Every 4 weeks, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 1-2 tablespoons) and urine will be collected for routine tests. Part of this blood will be used to measure your PSA and your levels of a specific marker of prostate cancer.
- You will be asked questions about how you are feeling and about any side effects you may have had since your last visit.
- You will be asked about any other drugs you may be taking.
- Your performance status will be recorded.
If the disease gets worse (or you change treatments) at any point in the study, the following tests and procedures will be performed:
- Blood (about 1-2 tablespoons) and urine will be collected for routine tests.
- You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease.
- You will have an ECG and an echocardiogram or a MUGA scan.
- You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease.
If your doctor thinks it is necessary:
°You will have a chest x-ray, CT scans of your abdomen and pelvis, and a bone scan to check the status of your disease.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will be taken off study if the disease gets worse after crossover, if you experience intolerable side effects, or if the doctor thinks that it is in your best interest.
End of Treatment Visit:
After you stop receiving the study drugs for any reason, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your PSA level, your level of a specific marker of prostate cancer, and to check for a protein related to cancer.
- You will be asked questions about how you are feeling and about any side effects you may have had since your last visit.
- You will be asked about any other drugs you may be taking.
- Your performance status will be recorded.
- You will have a bone marrow aspiration and biopsy or a tumor tissue biopsy to collect tumor tissue from places to which the tumor has spread to check the status of the disease.
Post-Treatment (Safety) Follow-Up Visit:
About 30 days after your last dose of study drugs, the following tests and procedures will be performed:
- You will have a physical exam, including a measurement of your vital signs.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
- Your performance status will be recorded.
- You will be asked about any side effects you may have experienced since your last visit.
- You will be asked about any other drugs you may be taking.
Long-Term Follow-Up:
A member of the study staff will check up on you about every 6 months after your Post-Treatment (Safety) Follow-Up Visit. This will consist of a phone call, an e-mail, or a review of your medical and/or other records. If you are contacted by phone, the call will only last a few minutes.
After your End-of-Treatment visit, the study staff will contact you by phone, e-mail, or you will come in for a clinic visit. You will be asked about how you are feeling and any side effects you may have had. Each follow-up will take about 5 minutes. Follow-up will take place every 3 months for the first 2 years, every 6 months for the third year, and 1 time a year after that. The last follow-up will be about 5 years after the last patient is enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abiraterone Acetate + Prednisone (AP) | Experimental | Drug: Abiraterone Acetate, Drug: PrednisoneAbiraterone Acetate at 1000 mg orally each day, given in combination with 5 mg of Prednisone orally twice daily. |
| Group 1: AP + Sunitinib | Experimental | Drug: Abiraterone Acetate, Drug: Prednisone, Drug: SunitinibAP (Abiraterone Acetate + Prednisone) Plus Sunitinib; Randomized from AP group to receive Sunitinib if disease worsens. Assignment to crossover group AP + Dasatinib with further disease progression. |
| Group 2: AP + Dasatinib | Experimental | Drug: Abiraterone Acetate, Drug: Prednisone, Drug: DasatinibAP (Abiraterone Acetate + Prednisone) Plus Dasatinib; Randomized from AP group to receive Dasatinib if disease worsens. Assignment to crossover group AP + Sunitinib with further disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Willing and able to provide written informed consent
- Male aged 18 years and above
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT or MRI.
- Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
Key exclusion criteria (23 listed)
- Active infection (requiring oral or IV antibiotics) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily.
- Pathological finding consistent with small cell carcinoma of the prostate
- Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1. Patients who have received palliative radiation to a single site and recovered are eligible.
- No malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone AcetateAlso: CB76301000 mg by mouth each day of a 28 day cycle. | Drug | Abiraterone Acetate + Prednisone (AP), Group 1: AP + Sunitinib, Group 2: AP + Dasatinib |
| Prednisone5 mg by mouth twice daily of a 28 day cycle. | Drug | Abiraterone Acetate + Prednisone (AP), Group 1: AP + Sunitinib, Group 2: AP + Dasatinib |
| SunitinibAlso: Sunitinib Malate, SUO11248, Sutent37.5 mg by mouth daily for two weeks followed by a week of rest in a 28 day cycle. | Drug | Group 1: AP + Sunitinib |
| DasatinibAlso: BMS-354825, Sprycel100 mg by mouth each day of a 28 day cycle. | Drug | Group 2: AP + Dasatinib |
Primary outcome
Time to Treatment Failure (TTF)
Time frame: Up to 11 months
Time to treatment failure (TTF), defined as time from randomization (AP+S or AP+D) to progression per PCWG2 criteria or death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36100698Sakellakis MJ, Hahn AW, Ramachandran S, Zhang M, Hoang A, Song JH, Liu J, Wang F, Basu HS, Sheperd P, Wang X, Frigo DE, Lin SH, Panaretakis T, Zhang J, Navone N, Troncoso P, Logothetis CJ, Titus MA. Characterization of prostate cancer adrenal metastases: dependence upon androgen receptor signaling and steroid hormones. Prostate Cancer Prostatic Dis. 2023 Dec;26(4):751-758. doi: 10.1038/s41391-022-00590-x. Epub 2022 Sep 13.
- Derived from this study: PubMed 31986451Boukovala M, Spetsieris N, Weldon JA, Tsikkinis A, Hoang A, Aparicio A, Tu SM, Araujo JC, Zurita AJ, Corn PG, Pagliaro L, Kim J, Wang J, Subudhi SK, Tannir NM, Logothetis CJ, Troncoso P, Wen S, Efstathiou E. A candidate androgen signalling signature predictive of response to abiraterone acetate in men with metastatic castration-resistant prostate cancer. Eur J Cancer. 2020 Mar;127:67-75. doi: 10.1016/j.ejca.2019.12.027. Epub 2020 Jan 24.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Corn, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone Acetate, Prednisone and Sunitinib in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure (TTF) (time frame: Up to 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01254864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.