Prostate CancerPhase 2NCT02867020

Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels

A Phase 2 study testing Apalutamide, Abiraterone and ADT in people with Prostate Cancer, run by Latin American Cooperative Oncology Group at 14 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Evaluation of the activity, safety and patients reported outcome of ADT plus abiraterone, abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone in hormone naïve locally advanced or metastatic prostate cancer which ADT was indicated. 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?: Apalutamide, Abiraterone and ADT
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 14 sitesBrazil
Study dates: 11 Oct 2017to 30 Jun 2021
Phase: Phase 2
Are there results?: None posted in the registry

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

Histologically confirmed prostate adenocarcinoma;
Hormone naïve patients with indication to ADT in the following settings:
Advanced loco-regional disease not amenable to curative local therapy (surgery or radiotherapy): T category T3/4 or node positive
Biochemical relapse after primary treatment (surgery or radiotherapy): patients in whom primary therapy is not appropriate or feasible with Previously treated with radical surgery and/or radiotherapy, now relapsing with at least one of the criteria: PSA >= 4 ng/ml and rising with doubling time less than 10 months. or PSA >= 20 ng/ml or N+ or M+
Newly diagnosed metastatic disease: Tany Nany M+
Patient is asymptomatic or moderately symptomatic regarding bone symptoms, i.e., no need for palliative radiation or radionuclide therapy;

Show all 17Show fewer

Non-castration level of testosterone > 230ng/dL (> 8 nmol/L);
Baseline level of prostatespecific antigen (PSA) > 2ng/dL;
ECOG performance status of 0 to 2;
Adequate hematologic, hepatic and renal function:
hemoglobin > 10 g/dL, neutrophils > 1.5×109 / L, platelets> 100×109 / L;
total bilirubin < 1.5x upper limit of normal (ULN); alanine (ALT) and aspartate (AST) aminotransferase < 2.5 x ULN;
serum creatinine < 1.5x ULN; potassium > 3.5 mM;
No previous cancer (except treated basal-cell skin cancer);
Written informed consent obtained prior to any study procedure;
Men age 18 years and older;
Agrees to use a condom and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant.

Who cannot join

Prostate adenocarcinoma with neuroendocrine differentiation or small cell histology;
Biochemical recurrence without evidence of clinical or radiological disease;
Use of hormonal therapy or chemotherapy prior to randomization. Exception is courses of hormone therapy for localised disease must have been completed at least 12 months previously. It can have been given as adjuvant or neoadjuvant therapy.
Prior radiation therapy for a primary tumour within the 3 months before enrollment or for the treatment of metastases;
Known or suspected brain or skull metastases or leptomeningeal metastatic disease;
Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study;

Show all 24Show fewer

Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 28 days of Cycle 1 Day 1 or currently enrolled in an investigational study;
Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction;
Current or prior treatment with anti-epileptic medications for the treatment of seizures;
Impaired cardiac function, including any of the following:
Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥95 mmHg);
Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events or history of cardiac failure in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease;
Existing atrial fibrillation with or without pharmacotherapy. Other cardiac arrhythmia requiring pharmacotherapy;
History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect);
Specific underlying conditions for oral agents. For example: impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of abiraterone or APALUTAMIDE (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
General excluded medications (e.g., relevant to cytochrome P450 interactions)
Use of prescription drugs within 14 days prior to dosing or over-the-counter (OTC) medication within 7 days prior to dosing;
Consumption of grapefruit product or St John's wort within 7 days prior to dosing;
G-CSF, GM-CSF, erythropoietin, etc;
Coumadin;
Drugs which may cause QT prolongation;
Known sensitivity to drugs or metabolites from similar classes;
Known or suspected contraindications or hypersensitivity to APALUTAMIDE, bicalutamide or GnRH agonists or any of the components of the formulations;
Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subject's participation in this study.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Brazil14 sites

Hospital de Câncer de Barretos
Barretos, São Paulo
Hospital Erasto Gaertner
Curitiba, Paraná
CRIO
Fortaleza, Ceará
Hospital de Caridade de Ijuí
Ijuí, Rio Grande do Sul
Liga Norte Riograndense de Oncologia
Natal, Rio Grande do Norte
CPO - Pucrs
Porto Alegre, Rio Grande do Sul
Oncologia Rede D'Or S.A.
Rio de Janeiro, Rio de Janeiro, 22281 100
Grupo COI
Rio de Janeiro
Clínica AMO
Salvador, Estado de Bahia
Centro de Pesquisa Clínica em Hematologia e Oncologia - CEPHO
Santo André, São Paulo
Beneficiencia Portuguesa de São Paulo/Hospital São José
São Paulo
Hospital Israelita Albert Einstein
São Paulo
IBCC
São Paulo
ICESP
São Paulo

Other trials in Brazil

About this study

Official title: Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels

Read the detailed description

Based on the current guidelines, ADT alone or combined with is antiandrogens are considered the appropriate active therapy for the patient population planned for this study. Recent data showed that chemotherapy also benefit patients in this setting. Even though, there is a clear unmet medical need for alternative treatment option in metastatic hormone sensitive prostate cancer (mHSPC). Treatments that can delay disease progression, and are associated with less comorbidities would be of significant clinical benefit in this patient population. The study is designed to assess the efficacy and safety of abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone without castration side effects and the other arm a combination of ADT and abiraterone; this last arm is to reflect an Abiraterone ongoing pivotal trial (LATITUDE), that assess the efficacy of adding abiraterone to castration in this setting of patients. Abiraterone had already showed clinical benefit in CRPC patients without prior chemotherapy.

Conditions: Prostate Cancer
Being tested: Apalutamide, Abiraterone, ADT, Prednisone
Keywords: apalutamide, abiraterone, prostate cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApalutamideDrug
APALUTAMIDE 240-mg orally once daily (4 x 60-mg tablets) will be administered on a continual basis. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days.
AbirateroneDrug
Abiraterone acetate 1,000 mg (four 250 mg tablets) should be taken orally once daily, in combination with oral dose prednisone 5mg twice daily continuously. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days
ADTDrug
Also called Goserelin
Dosing of goserelin (dose and frequency of administration) will be consistent with the prescribing information and should only be adjusted if clinically indicated to achieve and maintain subcastrate concentrations of testosterone (50 ng/dL or 1.7 nM).
PrednisoneDrug
Subjects will receive prednisone 10mg/day.

Study groups in NCT02867020
Study group	Role	What they receive
Abiraterone acetate + Prednisone + ADT (Goserelin)	Active comparator	* Abiraterone administered at a single 1000 mg daily oral dose (4 x 250-mg tablets) * Prednisone administered at a 5 mg twice daily oral dose * Goserelin administered as subcutaneous injections of 10.8mg every 3 months Receives: Drug: Apalutamide; Drug: Abiraterone; Drug: ADT
APALUTAMIDE monotherapy	Experimental	o APALUTAMIDE administered at a single 240 mg daily oral dose (4 x 60 mg tablets) Receives: Drug: Apalutamide
Abiraterone acetate + Prednisone + APALUTAMIDE	Experimental	* Abiraterone administered at a single 1000 mg daily oral dose (4 x 250 mg tablets) * Prednisone administered at a 5 mg twice daily oral dose * APALUTAMIDE administered at a single 240 mg daily oral dose (4 x 60 mg tablets) Receives: Drug: Apalutamide; Drug: Abiraterone; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients that achieves an undetectable PSA level, defined as ≤ 0.2 ng/mL
Measured: Week 25

Secondary outcomes (18)

PSA progression rate
Determination of PSA progression rate among the three experimental arms
Measured: Week 25
Comparison of PSA progression rate
Comparison of PSA progression rate among the three experimental arms
Measured: Week 25
PSA response of 50 and 80%
Determination of PSA response of 50 and 80% among the three experimental arms
Measured: Week 25
Comparison of PSA response of 50 and 80%
Comparison of PSA response of 50 and 80% among the three experimental arms
Measured: Week 25
Maximum PSA declines
Determination of maximum PSA declines among the three experimental arms
Measured: Baseline up to week 25 to 52
Overall PSA change
Determination of overall PSA change among the three experimental arms
Measured: Baseline up to week 25 to 52
Hormonal levels during treatment
Measured: Baseline up to week 25
Comparison of hormonal levels during treatment
Comparison of hormonal levels during treatment among the three experimental arms
Measured: Baseline up to week 25
Evaluation of bone mineral density according to RECIST 1.1
Measured: Week 25
Comparison of bone mineral density according to RECIST 1.1 between three experimental groups
Measured: Week 25
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Baseline to 2 years of follow-up
Number of participants with pain progression assessed by BPI-SF of three experimental arms
Measured: Baseline up to week 25
Number of participants in opioid use during treatment among three experimental arms
Measured: Baseline up to week 25
Comparison of pain progression assessed by opioid use
Comparison of pain progression assessed by opioid use between the experimental arms
Measured: Baseline up to week 25
Comparison of pain progression assessed by BPI-SF questionnaire
Comparison of pain progression assessed by BPI-SF between the experimental arms
Measured: Baseline up to week 25
Quality of life assessed by FACT-P questionnaire
Quality of life assessed by FACT-P questionnaire of the experimental arms
Measured: Baseline up to week 25
Comparison of quality of life assessed by FACT-P questionnaire
Comparison of quality of life assessed by FACT-P questionnaire between the experimental arms
Measured: Baseline up to week 25
Radiographic progression-free survival (rPFS)
Radiographic progression-free survival (rPFS) among the experimental arms
Measured: Week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 201730 Jun 2021

First posted15 Aug 2016 (estimated)
Study start11 Oct 2017
Primary completion9 Oct 2019
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
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: Parallel groups
Masking: None (open label)
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02867020
Sponsor's protocol ID: LACOG 0415
Status last verified: Jul 2021
First submitted: 8 Aug 2016
Last updated: 7 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hershman DL, Unger JM, Wright JD, Ramsey S, Till C, Tangen CM, Barlow WE, Blanke C, Thompson IM, Hussain M. Adverse Health Events Following Intermittent and Continuous Androgen Deprivation in Patients With Metastatic Prostate Cancer. JAMA Oncol. 2016 Apr;2(4):453-61. doi: 10.1001/jamaoncol.2015.4655.
PubMed 26720308
Rozet F, Roumeguere T, Spahn M, Beyersdorff D, Hammerer P. Non-metastatic castrate-resistant prostate cancer: a call for improved guidance on clinical management. World J Urol. 2016 Nov;34(11):1505-1513. doi: 10.1007/s00345-016-1803-9. Epub 2016 Mar 17.
PubMed 26988552
Crawford ED, Higano CS, Shore ND, Hussain M, Petrylak DP. Treating Patients with Metastatic Castration Resistant Prostate Cancer: A Comprehensive Review of Available Therapies. J Urol. 2015 Dec;194(6):1537-47. doi: 10.1016/j.juro.2015.06.106. Epub 2015 Jul 18.
PubMed 26196735
Gartrell BA, Coleman R, Efstathiou E, Fizazi K, Logothetis CJ, Smith MR, Sonpavde G, Sartor O, Saad F. Metastatic Prostate Cancer and the Bone: Significance and Therapeutic Options. Eur Urol. 2015 Nov;68(5):850-8. doi: 10.1016/j.eururo.2015.06.039. Epub 2015 Jul 4.
PubMed 26153564
Barrie SE, Potter GA, Goddard PM, Haynes BP, Dowsett M, Jarman M. Pharmacology of novel steroidal inhibitors of cytochrome P450(17) alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol. 1994 Sep;50(5-6):267-73. doi: 10.1016/0960-0760(94)90131-7.
PubMed 7918112
Attard G, Reid AH, A'Hern R, Parker C, Oommen NB, Folkerd E, Messiou C, Molife LR, Maier G, Thompson E, Olmos D, Sinha R, Lee G, Dowsett M, Kaye SB, Dearnaley D, Kheoh T, Molina A, de Bono JS. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J Clin Oncol. 2009 Aug 10;27(23):3742-8. doi: 10.1200/JCO.2008.20.0642. Epub 2009 May 26.
PubMed 19470933
Attard G, Reid AH, Yap TA, Raynaud F, Dowsett M, Settatree S, Barrett M, Parker C, Martins V, Folkerd E, Clark J, Cooper CS, Kaye SB, Dearnaley D, Lee G, de Bono JS. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J Clin Oncol. 2008 Oct 1;26(28):4563-71. doi: 10.1200/JCO.2007.15.9749. Epub 2008 Jul 21.
PubMed 18645193
Danila DC, Morris MJ, de Bono JS, Ryan CJ, Denmeade SR, Smith MR, Taplin ME, Bubley GJ, Kheoh T, Haqq C, Molina A, Anand A, Koscuiszka M, Larson SM, Schwartz LH, Fleisher M, Scher HI. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 20;28(9):1496-501. doi: 10.1200/JCO.2009.25.9259. Epub 2010 Feb 16.
PubMed 20159814
O'Donnell A, Judson I, Dowsett M, Raynaud F, Dearnaley D, Mason M, Harland S, Robbins A, Halbert G, Nutley B, Jarman M. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer. 2004 Jun 14;90(12):2317-25. doi: 10.1038/sj.bjc.6601879.
PubMed 15150570
Reid AH, Attard G, Danila DC, Oommen NB, Olmos D, Fong PC, Molife LR, Hunt J, Messiou C, Parker C, Dearnaley D, Swennenhuis JF, Terstappen LW, Lee G, Kheoh T, Molina A, Ryan CJ, Small E, Scher HI, de Bono JS. Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clin Oncol. 2010 Mar 20;28(9):1489-95. doi: 10.1200/JCO.2009.24.6819. Epub 2010 Feb 16.
PubMed 20159823
Ryan CJ, Shah S, Efstathiou E, Smith MR, Taplin ME, Bubley GJ, Logothetis CJ, Kheoh T, Kilian C, Haqq CM, Molina A, Small EJ. Phase II study of abiraterone acetate in chemotherapy-naive metastatic castration-resistant prostate cancer displaying bone flare discordant with serologic response. Clin Cancer Res. 2011 Jul 15;17(14):4854-61. doi: 10.1158/1078-0432.CCR-11-0815. Epub 2011 Jun 1.
PubMed 21632851
Ryan CJ, Smith MR, Fong L, Rosenberg JE, Kantoff P, Raynaud F, Martins V, Lee G, Kheoh T, Kim J, Molina A, Small EJ. Phase I clinical trial of the CYP17 inhibitor abiraterone acetate demonstrating clinical activity in patients with castration-resistant prostate cancer who received prior ketoconazole therapy. J Clin Oncol. 2010 Mar 20;28(9):1481-8. doi: 10.1200/JCO.2009.24.1281. Epub 2010 Feb 16.
PubMed 20159824
de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.
PubMed 21612468
Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18.
PubMed 22995653
Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.
PubMed 23228172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels
ClinicalTrials.gov ID: NCT02867020
Acronym / sponsor ID: LACOG 0415
Conditions: Prostate Cancer
Keywords: apalutamide, abiraterone, prostate cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Latin American Cooperative Oncology GroupUniversity, hospital or other
Collaborators: Janssen Pharmaceuticals
Study start: 11 Oct 2017 (actual)
Primary completion: 9 Oct 2019 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 15 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Abiraterone acetate + Prednisone + ADT (Goserelin)	Active comparator	Drug: Apalutamide, Drug: Abiraterone, Drug: ADT* Abiraterone administered at a single 1000 mg daily oral dose (4 x 250-mg tablets) * Prednisone administered at a 5 mg twice daily oral dose * Goserelin administered as subcutaneous injections of 10.8mg every 3 months
APALUTAMIDE monotherapy	Experimental	Drug: Apalutamideo APALUTAMIDE administered at a single 240 mg daily oral dose (4 x 60 mg tablets)
Abiraterone acetate + Prednisone + APALUTAMIDE	Experimental	Drug: Apalutamide, Drug: Abiraterone, Drug: Prednisone* Abiraterone administered at a single 1000 mg daily oral dose (4 x 250 mg tablets) * Prednisone administered at a 5 mg twice daily oral dose * APALUTAMIDE administered at a single 240 mg daily oral dose (4 x 60 mg tablets)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Histologically confirmed prostate adenocarcinoma;
Hormone naïve patients with indication to ADT in the following settings:
Patient is asymptomatic or moderately symptomatic regarding bone symptoms, i.e., no need for palliative radiation or radionuclide therapy;
Non-castration level of testosterone > 230ng/dL (> 8 nmol/L);
Baseline level of prostatespecific antigen (PSA) > 2ng/dL;

Key exclusion criteria (24 listed)

Prostate adenocarcinoma with neuroendocrine differentiation or small cell histology;
Biochemical recurrence without evidence of clinical or radiological disease;
Use of hormonal therapy or chemotherapy prior to randomization. Exception is courses of hormone therapy for localised disease must have been completed at least 12 months previously. It can have been given as adjuvant or neoadjuvant therapy.
Prior radiation therapy for a primary tumour within the 3 months before enrollment or for the treatment of metastases;
Known or suspected brain or skull metastases or leptomeningeal metastatic disease;

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
ApalutamideAPALUTAMIDE 240-mg orally once daily (4 x 60-mg tablets) will be administered on a continual basis. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days.	Drug	APALUTAMIDE monotherapy, Abiraterone acetate + Prednisone + ADT (Goserelin), Abiraterone acetate + Prednisone + APALUTAMIDE
AbirateroneAbiraterone acetate 1,000 mg (four 250 mg tablets) should be taken orally once daily, in combination with oral dose prednisone 5mg twice daily continuously. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days	Drug	Abiraterone acetate + Prednisone + ADT (Goserelin), Abiraterone acetate + Prednisone + APALUTAMIDE
ADTAlso: GoserelinDosing of goserelin (dose and frequency of administration) will be consistent with the prescribing information and should only be adjusted if clinically indicated to achieve and maintain subcastrate concentrations of testosterone (50 ng/dL or 1.7 nM).	Drug	Abiraterone acetate + Prednisone + ADT (Goserelin)
PrednisoneSubjects will receive prednisone 10mg/day.	Drug	Abiraterone acetate + Prednisone + APALUTAMIDE

Primary outcome

Number of patients that achieves an undetectable PSA level, defined as ≤ 0.2 ng/mL
Time frame: Week 25

18 secondary outcomes

PSA progression rate
Time frame: Week 25
Comparison of PSA progression rate
Time frame: Week 25
PSA response of 50 and 80%
Time frame: Week 25
Comparison of PSA response of 50 and 80%
Time frame: Week 25
Maximum PSA declines
Time frame: Baseline up to week 25 to 52
Overall PSA change
Time frame: Baseline up to week 25 to 52
Hormonal levels during treatment
Time frame: Baseline up to week 25
Comparison of hormonal levels during treatment
Time frame: Baseline up to week 25
Evaluation of bone mineral density according to RECIST 1.1
Time frame: Week 25
Comparison of bone mineral density according to RECIST 1.1 between three experimental groups
Time frame: Week 25
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Baseline to 2 years of follow-up
Number of participants with pain progression assessed by BPI-SF of three experimental arms
Time frame: Baseline up to week 25
Number of participants in opioid use during treatment among three experimental arms
Time frame: Baseline up to week 25
Comparison of pain progression assessed by opioid use
Time frame: Baseline up to week 25
Comparison of pain progression assessed by BPI-SF questionnaire
Time frame: Baseline up to week 25
Quality of life assessed by FACT-P questionnaire
Time frame: Baseline up to week 25
Comparison of quality of life assessed by FACT-P questionnaire
Time frame: Baseline up to week 25
Radiographic progression-free survival (rPFS)
Time frame: Week 25

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
Background: PubMed 26720308Hershman DL, Unger JM, Wright JD, Ramsey S, Till C, Tangen CM, Barlow WE, Blanke C, Thompson IM, Hussain M. Adverse Health Events Following Intermittent and Continuous Androgen Deprivation in Patients With Metastatic Prostate Cancer. JAMA Oncol. 2016 Apr;2(4):453-61. doi: 10.1001/jamaoncol.2015.4655.
Background: PubMed 26988552Rozet F, Roumeguere T, Spahn M, Beyersdorff D, Hammerer P. Non-metastatic castrate-resistant prostate cancer: a call for improved guidance on clinical management. World J Urol. 2016 Nov;34(11):1505-1513. doi: 10.1007/s00345-016-1803-9. Epub 2016 Mar 17.
Background: PubMed 26196735Crawford ED, Higano CS, Shore ND, Hussain M, Petrylak DP. Treating Patients with Metastatic Castration Resistant Prostate Cancer: A Comprehensive Review of Available Therapies. J Urol. 2015 Dec;194(6):1537-47. doi: 10.1016/j.juro.2015.06.106. Epub 2015 Jul 18.
Background: PubMed 26153564Gartrell BA, Coleman R, Efstathiou E, Fizazi K, Logothetis CJ, Smith MR, Sonpavde G, Sartor O, Saad F. Metastatic Prostate Cancer and the Bone: Significance and Therapeutic Options. Eur Urol. 2015 Nov;68(5):850-8. doi: 10.1016/j.eururo.2015.06.039. Epub 2015 Jul 4.
Background: PubMed 7918112Barrie SE, Potter GA, Goddard PM, Haynes BP, Dowsett M, Jarman M. Pharmacology of novel steroidal inhibitors of cytochrome P450(17) alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol. 1994 Sep;50(5-6):267-73. doi: 10.1016/0960-0760(94)90131-7.
Background: PubMed 19470933Attard G, Reid AH, A'Hern R, Parker C, Oommen NB, Folkerd E, Messiou C, Molife LR, Maier G, Thompson E, Olmos D, Sinha R, Lee G, Dowsett M, Kaye SB, Dearnaley D, Kheoh T, Molina A, de Bono JS. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J Clin Oncol. 2009 Aug 10;27(23):3742-8. doi: 10.1200/JCO.2008.20.0642. Epub 2009 May 26.
Background: PubMed 18645193Attard G, Reid AH, Yap TA, Raynaud F, Dowsett M, Settatree S, Barrett M, Parker C, Martins V, Folkerd E, Clark J, Cooper CS, Kaye SB, Dearnaley D, Lee G, de Bono JS. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J Clin Oncol. 2008 Oct 1;26(28):4563-71. doi: 10.1200/JCO.2007.15.9749. Epub 2008 Jul 21.
Background: PubMed 20159814Danila DC, Morris MJ, de Bono JS, Ryan CJ, Denmeade SR, Smith MR, Taplin ME, Bubley GJ, Kheoh T, Haqq C, Molina A, Anand A, Koscuiszka M, Larson SM, Schwartz LH, Fleisher M, Scher HI. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 20;28(9):1496-501. doi: 10.1200/JCO.2009.25.9259. Epub 2010 Feb 16.
Background: PubMed 15150570O'Donnell A, Judson I, Dowsett M, Raynaud F, Dearnaley D, Mason M, Harland S, Robbins A, Halbert G, Nutley B, Jarman M. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer. 2004 Jun 14;90(12):2317-25. doi: 10.1038/sj.bjc.6601879.
Background: PubMed 20159823Reid AH, Attard G, Danila DC, Oommen NB, Olmos D, Fong PC, Molife LR, Hunt J, Messiou C, Parker C, Dearnaley D, Swennenhuis JF, Terstappen LW, Lee G, Kheoh T, Molina A, Ryan CJ, Small E, Scher HI, de Bono JS. Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clin Oncol. 2010 Mar 20;28(9):1489-95. doi: 10.1200/JCO.2009.24.6819. Epub 2010 Feb 16.
Background: PubMed 21632851Ryan CJ, Shah S, Efstathiou E, Smith MR, Taplin ME, Bubley GJ, Logothetis CJ, Kheoh T, Kilian C, Haqq CM, Molina A, Small EJ. Phase II study of abiraterone acetate in chemotherapy-naive metastatic castration-resistant prostate cancer displaying bone flare discordant with serologic response. Clin Cancer Res. 2011 Jul 15;17(14):4854-61. doi: 10.1158/1078-0432.CCR-11-0815. Epub 2011 Jun 1.
Background: PubMed 20159824Ryan CJ, Smith MR, Fong L, Rosenberg JE, Kantoff P, Raynaud F, Martins V, Lee G, Kheoh T, Kim J, Molina A, Small EJ. Phase I clinical trial of the CYP17 inhibitor abiraterone acetate demonstrating clinical activity in patients with castration-resistant prostate cancer who received prior ketoconazole therapy. J Clin Oncol. 2010 Mar 20;28(9):1481-8. doi: 10.1200/JCO.2009.24.1281. Epub 2010 Feb 16.

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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.

Fernando Maluf, MD principal investigator

Beneficiência Portuguesa de São Paulo

Gustavo Werutsky, MD study director

Latin American Cooperative Oncology Group

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apalutamide, Abiraterone and ADT in people with Prostate Cancer, run by Latin American Cooperative Oncology Group at 14 sites in Brazil.

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 17 inclusion and 24 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of patients that achieves an undetectable PSA level, defined as ≤ 0.2 ng/mL (time frame: Week 25). 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 NCT02867020, which also lists 23 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 7 Jul 2021.