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Prostate CancerPhase 3NCT03009981

A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

A Phase 3 study testing Apalutamide, LHRH Analogue and Abiraterone Acetate in people with Prostate Cancer, run by Alliance Foundation Trials, LLC. at 69 sites in United States.

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

This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry. 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, LHRH Analogue and Abiraterone Acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
504 participants
Where
69 sitesUnited States
Study dates
6 Mar 2017to 25 Jun 2025
Phase
Phase 3
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
  • Prior radical prostatectomy
  • Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 6-12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to therapeutic interventions (e.g. salvage radiation) will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator (https://www.mskcc.org/nomograms/prostate/psa-doubling-time)
  • Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient co-morbidities.
  • Screening PSA > 0.5 ng/mL
  • No definitive evidence of metastases on screening CT or MRI of abdomen/pelvis and radionuclide whole body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 2 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. PSMA or choline PET) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated.
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  • Screening serum testosterone > 150 ng/dL
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1
  • Age ≥ 18 years
  • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to cycle 1 day 1
  • Agrees to use a condom (even men with vasectomies) 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 while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
  • Adequate organ function as defined by the following laboratory values at screening:
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) < 2.5 x upper limit of normal (ULN)
  • Total serum bilirubin ≤1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
  • Serum potassium ≥ 3.5 mmol/L. Supplementation and re-screening is allowed.
  • Estimated creatinine clearance > 45 ml/min using Cockroft-Gault equation
  • Platelets ≥ 100,000/microliter independent of transfusion and/or growth factors within 3 months prior to randomization
  • Hemoglobin ≥ 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to randomization
  • Serum albumin ≥ 3.0 g/dL

Who cannot join

  • Prior androgen deprivation therapy and/or first generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage setting before, during, and/or following radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to date of randomization and total duration of prior therapy is ≤ 36 months.
  • Prior treatment with CYP17 inhibitor (e.g. ketoconazole, abiraterone acetate, galeterone) or second generation androgen receptor antagonist including apalutamide or enzalutamide
  • Prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting
  • Use of 5-alpha reductase inhibitor within 42 days prior to cycle 1 day 1
  • Use of investigational agent within 28 days prior to randomization
  • Use of other prohibited medications within 7 days prior to cycle 1 day 1 on study (Arms B and C only)
Show all 13Show fewer
  • Prior bilateral orchiectomy
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
  • Uncontrolled hypertension
  • Gastrointestinal disorder affecting absorption or the ability to swallow tablets
  • Baseline severe hepatic impairment (Child-Pugh Class B \& C)
  • Intercurrent illness that is not controlled such as active infection, psychiatric illness/social situations that would limit compliance with study requirements
  • Any chronic medical condition requiring a higher dose of corticosteroid than equivalent of 5 mg prednisone/prednisolone once daily

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Eastern Maine Medical Center

    Brewer, Maine, 04412

  • VA Western New York

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Dayton Physicians Miami Valley South

    Centerville, Ohio, 45459

  • University of North Carolina Hospital

    Chapel Hill, North Carolina, 27514

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 606012

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Sharp Memorial Hospital

    Chula Vista, California, 91911

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Cancer Center

    Commack, New York, 11725

  • New Hampshire Oncology & Hematology

    Concord, New Hampshire, 03301

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Northshore University Health System

    Evanston, Illinois, 60201

  • Palo Alto Medical Foundation

    Fremont, California, 94538

  • VA Central California Health Care System

    Fresno, California, 93703

  • Memorial Sloan Kettering Cancer Center

    Harrison, New York, 11533

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • New Hampshire Oncology & Hematology

    Hooksett, New Hampshire, 03106

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • New England Cancer Specialists

    Kennebunk, Maine, 04043

  • Sharp Memorial Hospital

    La Mesa, California, 91942

  • Memorial Medical Center- Cancer Center

    Las Cruces, New Mexico, 88011

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Marshfield Clinic Cancer Center

    Marshfield, Wisconsin, 54449

  • Loyola University

    Maywood, Illinois, 60153

  • Memorial Sloan Kettering Cancer Center

    Middletown, New Jersey, 07748

  • Dana Farber Cancer Institute

    Milford, Massachusetts, 01757

  • Froedtert Hospital/Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Atlantic Health System/Morristown Medical Center

    Morristown, New Jersey, 07962

  • Palo Alto Medical Foundation

    Mountain View, California, 94040

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical Ctr - New York Presbyterian Hospital

    New York, New York, 10065

  • Montefiore Medical Center

    New York, New York, 10461

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • The Mayo Clinic - Phoenix

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • VA Salisbury

    Salisbury, North Carolina, 28144

  • University of California San Diego - Moores Cancer Center

    San Diego, California, 92093

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • University of California San Francisco

    San Francisco, California, 94158

  • Palo Alto Medical Foundation

    Santa Cruz, California, 95065

  • Christus St. Vincent's Regional Cancer Center

    Santa Fe, New Mexico, 87505

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Dana Farber Cancer Institute

    South Weymouth, Massachusetts, 02190

  • Spartanburg Medical Center/Gibbs Cancer Center

    Spartanburg, South Carolina, 29303

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Adventist Health St. Helena/St. Helena Hospital/Martin O'Neil Cancer Center

    St. Helena, California, 94574

  • Palo Alto Medical Foundation

    Sunnyvale, California, 94086

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • The Toledo Clinic

    Toledo, Ohio, 43623

  • New England Cancer Specialists

    Topsham, Maine, 04086

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20007

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.

Read the detailed description

Patients will be stratified by PSA doubling time (< 3 months vs. 3-9 months) and randomized in 1:1:1 fashion to one of three treatment arms: (1) Control arm consisting of LHRH analogue monotherapy (degarelix or leuprolide), (2) Experimental arm consisting of apalutamide in combination with LHRH analogue, and (3) Experimental arm consisting of apalutamide, abiraterone acetate + prednisone, and LHRH analogue. Patients will be treated for a maximum duration of 52 weeks and then enter follow up phase until the time of PSA progression, development of metastasis, or patient withdrawal from study, whichever occurs first. Patients with PSA progression will be followed long term until the development of castration resistance, first metastasis, and death.

The primary endpoint of the study is PSA progression-free survival in the intent-to-treat patient population. PSA progression during the 52-week treatment period is defined as a rising PSA confirmed on repeat measurement, and at least 25% and 2 ng/mL above nadir or baseline, whichever is lower. PSA progression during follow up defined as PSA > 0.2 ng/mL confirmed by repeat measurement at least 2 weeks later. Secondary study endpoints include PSA progression-free survival in testosterone-evaluable population, 36-month PSA progression-free survival rate in both intent-to-treat and testosterone-evaluable populations, time to testosterone recovery, time to castration resistance, metastasis-free survival, quality of life, and safety. Each experimental arm will be compared against the control arm in pair-wise fashion. The study is not powered to detect differences in primary or secondary endpoints between the two experimental arms.

Conditions
Prostate Cancer
Being tested
Apalutamide, LHRH Analogue, Abiraterone Acetate, Prednisone
Keywords
PSA, Degarelix, Apalutamide, Abiraterone Acetate, Radical Prostatectomy, Bicalutamide, Leuprolide, Lupron
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

    Also called Erleada

    Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.

  • LHRH AnalogueDrug

    Also called Degarelix (Firmagon), Leuprolide (Lupron) and Bicalutamide

    Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide.

    Degarelix:

    Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles.

    Leuprolide:

    Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion:

    1. Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide. OR:
    2. Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1.

  • Abiraterone AcetateDrug

    Also called Zytiga

    Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.

  • PrednisoneDrug

    Also called Deltasone

    Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.

Study groups in NCT03009981
Study groupRoleWhat they receive
Arm A: Degarelix Monotherapy OR Leuprolide/BicalutamideActive comparatorPatients will receive degarelix OR leuprolide with bicalutamide.
Receives: Drug: LHRH Analogue
Arm B: Degarelix/ApalutamideExperimentalPatients will receive apalutamide and either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
Receives: Drug: Apalutamide; Drug: LHRH Analogue
Arm C: Degarelix/Apalutamide/Abiraterone/PrednisoneExperimentalPatients will receive apalutamide and abiraterone acetate, in addition to either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.
Receives: Drug: Apalutamide; Drug: LHRH Analogue; Drug: Abiraterone Acetate; Drug: Prednisone

What is being measured

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

  1. PSA progression-free survival in the intent-to-treat population

    To compare PSA progression-free survival in each of the experimental arms (LHRH analogue + apalutamide; LHRH analogue + apalutamide +abiraterone acetate) versus the control arm (LHRH analogue) among all randomized patients (intent-to-treat population).

    Measured: 36 months

Secondary outcomes (12)

  1. PSA progression-free survival in the testosterone-evaluable population

    Compare PSA progression-free survival in testosterone-evaluable population in each experimental arm versus the control arm. Testosterone-evaluable population includes all patients who achieve serum testosterone recovery to > 50 ng/dL with subsequent PSA measurements sufficient for evaluation

    Measured: 36 months

  2. PSA progression-free survival in both the intent-to-treat and testosterone-evaluable populations

    To compare the 36-month PSA progression-free survival rate in each experimental arm versus the control arm in both the intent-to-treat and testosterone-evaluable populations.

    Measured: 36 months

  3. Serum testosterone

    To compare the time to recovery of serum testosterone to greater than 50 ng/dL in each experimental arm versus the control arm.

    Measured: 12 months

  4. Time to castration resistance

    To compare the time to castration resistance in each experimental arm versus the control arm.

    Measured: 6 years

  5. Metastasis-Free Survival

    To compare metastasis-free survival in each experimental arm versus the control arm.

    Measured: 6 years

  6. Overall Survival

    To compare overall survival in each experimental arm versus the control arm.

    Measured: 6 years

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    To characterize the safety profile in each treatment arm

    Measured: 6 years

  8. Quality of life Expanded Prostate Cancer Index Composite (EPIC)

    Expanded Prostate Cancer Index Composite (EPIC)

    Measured: 72 months

  9. Quality of life Hot Flash Daily Interference Scale (HFRDIS)

    Hot Flash Daily Interference Scale (HFRDIS)

    Measured: 72 months

  10. Quality of life EQ-5D-5L

    EQ-5D-5L

    Measured: 72 months

  11. Quality of life PROMIS Fatigue

    PROMIS Fatigue

    Measured: 72 months

  12. Quality-adjusted survival

    To compare the quality-adjusted survival (overall survival multiplied by utility score) of patients in each experimental arm versus the control arm.

    Measured: 72 months

Timeline

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

  1. First posted4 Jan 2017 (estimated)
  2. Study start6 Mar 2017
  3. Primary completion25 Jun 2025
  4. Study completion25 Jun 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009981
Sponsor's protocol ID
AFT-19
Status last verified
Oct 2025
First submitted
3 Jan 2017
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.

    PubMed 25559415

  • Zietman AL, Chung CS, Coen JJ, Shipley WU. 10-year outcome for men with localized prostate cancer treated with external radiation therapy: results of a cohort study. J Urol. 2004 Jan;171(1):210-4. doi: 10.1097/01.ju.0000100980.13364.a6.

    PubMed 14665878

  • Humphrey PA, Moch H, Cubilla AL, Ulbright TM, Reuter VE. The 2016 WHO Classification of Tumours of the Urinary System and Male Genital Organs-Part B: Prostate and Bladder Tumours. Eur Urol. 2016 Jul;70(1):106-119. doi: 10.1016/j.eururo.2016.02.028. Epub 2016 Mar 17.

    PubMed 26996659

  • Zelefsky MJ, Ben-Porat L, Scher HI, Chan HM, Fearn PA, Fuks ZY, Leibel SA, Venkatraman ES. Outcome predictors for the increasing PSA state after definitive external-beam radiotherapy for prostate cancer. J Clin Oncol. 2005 Feb 1;23(4):826-31. doi: 10.1200/JCO.2005.02.111.

    PubMed 15681527

  • Qu Y, Dai B, Ye D, Kong Y, Chang K, Jia Z, Yang X, Zhang H, Zhu Y, Shi G. Constitutively active AR-V7 plays an essential role in the development and progression of castration-resistant prostate cancer. Sci Rep. 2015 Jan 7;5:7654. doi: 10.1038/srep07654.

    PubMed 25563505

  • Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research. J Appl Meas. 2010;11(3):304-14.

    PubMed 20847477

  • Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.

    PubMed 38421252

  • Aggarwal R, Heller G, Hillman DW, Xiao H, Picus J, Taplin ME, Dorff T, Appleman L, Weckstein D, Patnaik A, Bryce A, Shevrin D, Mohler J, Anderson D, Rao A, Tagawa S, Tan A, Halabi S, Dooley K, O'Brien P, Chen R, Ryan CJ, Eggener SE, Morris MJ; EORTC-55994 Study Group. PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19). J Clin Oncol. 2024 Apr 1;42(10):1114-1123. doi: 10.1200/JCO.23.01157. Epub 2024 Jan 23.

    PubMed 38261983

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide, LHRH Analogue and Abiraterone Acetate in people with Prostate Cancer, run by Alliance Foundation Trials, LLC. at 69 sites 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 19 inclusion and 13 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

PSA progression-free survival in the intent-to-treat population (time frame: 36 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 NCT03009981, which also lists 8 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 18 Dec 2025.

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