New combo therapy aims to stall returning prostate cancer

NCT ID NCT03009981

Disease control Sponsor: Alliance Foundation Trials, LLC. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested whether adding apalutamide (Erleada) to standard hormone therapy (LHRH analogues) can delay cancer progression in men whose prostate cancer has returned after surgery. 504 men with rapidly rising PSA levels took part. The goal was to see if the combination keeps PSA levels from rising longer than hormone therapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Apalutamide (Erleada) and LHRH analogues (Degarelix, Leuprolide with Bicalutamide)
What this could lead to: If successful, this could offer a more effective way to delay PSA progression in men with prostate cancer that has returned after surgery.
What could go wrong: This is a completed phase 3 trial, but results may not apply to all patients. Hormone therapy can cause side effects like hot flashes, fatigue, and bone thinning.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

504 people

The number who actually took part.

Started

Mar 2017

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

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

St. Helena, California, 94574, United States
Atlantic Health System/Morristown Medical Center

Morristown, New Jersey, 07962, United States
Cancer Center of Kansas

Wichita, Kansas, 67214, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Christus St. Vincent's Regional Cancer Center

Santa Fe, New Mexico, 87505, United States
City of Hope National Medical Center

Duarte, California, 91010, United States
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute

Milford, Massachusetts, 01757, United States
Dana Farber Cancer Institute

South Weymouth, Massachusetts, 02190, United States
Dayton Physicians Miami Valley South

Centerville, Ohio, 45459, United States
Eastern Maine Medical Center

Brewer, Maine, 04412, United States
Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States
Loyola University

Maywood, Illinois, 60153, United States
Marshfield Clinic Cancer Center

Marshfield, Wisconsin, 54449, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20007, United States
Memorial Medical Center- Cancer Center

Las Cruces, New Mexico, 88011, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center

Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center

Harrison, New York, 11533, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States
Montefiore Medical Center

New York, New York, 10461, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States
New England Cancer Specialists

Kennebunk, Maine, 04043, United States
New England Cancer Specialists

Scarborough, Maine, 04074, United States
New England Cancer Specialists

Topsham, Maine, 04086, United States
New Hampshire Oncology & Hematology

Concord, New Hampshire, 03301, United States
New Hampshire Oncology & Hematology

Hooksett, New Hampshire, 03106, United States
New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87109, United States
Northshore University Health System

Evanston, Illinois, 60201, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146, United States
Oregon Health & Science University

Portland, Oregon, 97239, United States
Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States
Palo Alto Medical Foundation

Fremont, California, 94538, United States
Palo Alto Medical Foundation

Mountain View, California, 94040, United States
Palo Alto Medical Foundation

Palo Alto, California, 94301, United States
Palo Alto Medical Foundation

Santa Cruz, California, 95065, United States
Palo Alto Medical Foundation

Sunnyvale, California, 94086, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Quincy Medical Group

Quincy, Illinois, 62301, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rush University Medical Center

Chicago, Illinois, 606012, United States
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
Sharp Memorial Hospital

Chula Vista, California, 91911, United States
Sharp Memorial Hospital

La Mesa, California, 91942, United States
Sharp Memorial Hospital

San Diego, California, 92123, United States
Spartanburg Medical Center/Gibbs Cancer Center

Spartanburg, South Carolina, 29303, United States
The Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States
The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
The Toledo Clinic

Toledo, Ohio, 43623, United States
University of California San Diego - Moores Cancer Center

San Diego, California, 92093, United States
University of California San Francisco

San Francisco, California, 94158, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States
University of Minnesota

Minneapolis, Minnesota, 55455, United States
University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87131, United States
University of North Carolina Hospital

Chapel Hill, North Carolina, 27514, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
VA Central California Health Care System

Fresno, California, 93703, United States
VA Salisbury

Salisbury, North Carolina, 28144, United States
VA Western New York

Buffalo, New York, 14215, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Weill Cornell Medical Ctr - New York Presbyterian Hospital

New York, New York, 10065, United States

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