Current partner codePEPTIDESDE
NCT04557059·Phase 3·INTERVENTIONAL

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

Status

Active, not recruiting

Phase

Phase 3

Enrollment

692

Locations

141

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Interventions

Treatment arms and agents.

RADIATION

Radiotherapy

Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.

DRUG

LHRHa

Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.

DRUG

Apalutamide

Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.

Timeline

From registration to results.

  1. First posted

    Sep 21, 2020

  2. Study start

    Nov 12, 2020

  3. Primary completion

    Aug 27, 2029

  4. Study completion

    Sep 15, 2031

  5. Results posted

    Not reported

  6. Registry updated

    Jul 6, 2026

Outcomes

What the study measures.

Primary outcomes

Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)

Time frame · Up to 9 years

ppMPFS is defined as the appearance of at least one new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death.

Secondary outcomes

Time to Prostate-Specific Antigen (PSA) Progression

Time frame · Up to 9 years

Time to PSA progression is defined as the time from randomization to the date of first documentation of PSA progression. PSA progression is defined as a PSA concentration above the nadir of more than 0.5 nanogram per milliliter (ng/mL), confirmed by additional measurement at least 3 Weeks later.

PSA Response Rate

Time frame · Up to 9 years

PSA response rate is defined as the percentage of participants with a PSA decrease of \>= 50 percent (%), \>= 90% or undetectable from baseline.

PSA Levels at Week 26

Time frame · Week 26

PSA levels at week 26 will be reported.

Time to Loco-Regional Progression by PSMA-PET

Time frame · Up to 9 years

Time to loco-regional progression by PSMA-PET as assessed by blinded independent central review (BCIR) is defined as the time from randomization to the date of the first occurrence of PSMA-PET loco-regional progression. Criteria for PSMA-PET loco-regional progression: Appearance of at least one new PSMA-PET-positive loco-regional lesion compared with the previous scan.

Overall Survival

Time frame · Up to 9 years

Overall survival is defined as the time from randomization to date of death from any cause.

Prostate Cancer-Specific Survival

Time frame · Up to 9 years

Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.

Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)

Time frame · Up to 9 years

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (\<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (\>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA \>=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later * Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce * Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s). * High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (\>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (\<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score \>=8, evaluated from prostate tissue specimen at radical prostatectomy * Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m \[99mTc\] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization * Eastern Cooperative Oncology Group Performance Status Grade 0 or 1 Exclusion Criteria: * History of pelvic radiation for malignancy * Previous treatment with androgen deprivation therapy (ADT) for prostate cancer * Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed) * Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy * Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations * Prior chemotherapy for prostate cancer * Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening

Study locations

141 registered sites.

Australia · Austria · Belgium · Brazil · Czechia · Denmark · Finland · Germany · Hungary · Italy · Jordan · Lebanon · Mexico · Poland · Portugal · Russia · Slovakia · Spain · Sweden · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.

Arizona Urology Specialists

Tucson, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Urological Research Network

Hialeah, Florida, United States

First Urology, PSC

Jeffersonville, Indiana, United States

Michigan Institute of Urology

Troy, Michigan, United States

Associated Medical Professionals of Ny

Syracuse, New York, United States

The Urology Group

Cincinnati, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Urology Austin

Austin, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Spokane Urology

Spokane, Washington, United States

Bundaberg Hospital

Bundaberg, Australia

Hervey Bay Hospital

Bundaberg, Australia

Epworth Healthcare

East Melbourne, Australia

St Vincent's Hospital - Melbourne

Fitzroy, Australia

Genesis Care Hurstville

Hurstville, Australia

Macquarie University Hospital

North Ryde, Australia

Calvary Mater Newcastle

Waratah, Australia

GenesisCare Wembley

Wembley, Australia

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, Austria

Medizinische Universitaet Wien

Vienna, Austria

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Goserelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.