Prostatic NeoplasmsPhase 2NCT04523207

A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

A Phase 2 study testing Apalutamide, ADT and Relugolix in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 32 sites in United States.

Completed

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

Official record

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Trial summary

Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: Apalutamide, ADT and Relugolix
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 32 sitesUnited States
Study dates: 19 Aug 2020to 25 Oct 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

A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of <= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer
Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator
Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician
Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1
Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (>=) 20 ng/ml or; Gleason Score >= 9 in any core on biopsy or; Gleason Score >= 8 (4+4 or 5+3) in greater than (>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy

Who cannot join

History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (<) 2 centimeter (cm) in diameter [short axis] either radiographically or pathologically are allowed.)
History of bilateral orchiectomy
Received an investigational intervention <= 4 weeks before the planned first dose of study intervention
History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

Urology Austin
Austin, Texas, 78745
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga, New York, 14225
The Urology Group
Cincinnati, Ohio, 45212
The Urology Center of Colorado
Denver, Colorado, 80211
Urological Research Network
Hialeah, Florida, 33016
Houston Metro Urology
Houston, Texas, 77027
First Urology, PSC
Jeffersonville, Indiana, 47130
Foothills Urology - Golden Off
Lakewood, Colorado, 80228
Lancaster Urology
Lancaster, Pennsylvania, 17604
Arkansas Urology
Little Rock, Arkansas, 72211
Idaho Urologic Institute
Meridian, Idaho, 83642
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates
Nashville, Tennessee, 37209
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska, 68114
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Virginia Urology
Richmond, Virginia, 23235
Urology San Antonio Research
San Antonio, Texas, 78229
Skyline Urology
Sherman Oaks, California, 91411
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, 71106
Spokane Urology
Spokane, Washington, 99202
Oregon Urology Institute
Springfield, Oregon, 97477
Associated Medical Professionals
Syracuse, New York, 13210
Genesis Research
Torrance, California, 90505
Michigan Institute of Urology, PC
Troy, Michigan, 48084
Arizona Urology Specialists 1
Tucson, Arizona, 85704
Arizona Urology Specialists
Tucson, Arizona, 85741
Urology Of Virginia, Pllc
Virginia Beach, Virginia, 23462
New Jersey Urology LLC
Voorhees Township, New Jersey, 08043
Lexington Urology
West Columbia, South Carolina, 20169
The Iowa Clinic
West Des Moines, Iowa, 50266
Wichita Urology Group
Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.

Conditions: Prostatic Neoplasms
Being tested: Apalutamide, ADT, Relugolix
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 JNJ-56021927
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.
ADTDrug
Participants will receive ADT intramuscular or subcutaneously during the main study.
RelugolixDrug
Participants will receive 120 mg of relugolix following a loading dose of 360 mg of (3 tablets of 120 mg each) relugolix during the sub-study.

Study groups in NCT04523207
Study group	Role	What they receive
Apalutamide + Androgen Deprivation Therapy (ADT)	Experimental	In the main study, participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days). Participants who enrolled in the sub-study will receive apalutamide 240 mg once daily along with relugolix (a type of ADT) 120 mg once daily following a loading dose of 360 mg relugolix orally. Sub-study participants will be receiving relugolix up to Day 28 after which they will be transitioned into the main study from Cycle 2 Day 1 and will continue to receive conventional or oral ADT. Receives: Drug: Apalutamide; Drug: ADT; Drug: Relugolix

What is being measured

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

Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24
Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/mL). Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA > 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study.
Measured: At Month 24
Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28
Percentage of participants maintaining testosterone level <50 ng/dL through Day 28 were reported.
Measured: From Day -14 through Day 28

Secondary outcomes (3)

Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12
Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed PSA >0.2 ng/mL. Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA > 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study.
Measured: At Month 12
Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24
Percentage of participants with serum testosterone recovery (>=150 ng/dL) at Months 18 and 24 were reported. Testosterone recovery was defined as a serum testosterone level greater than or equal to (>=)150 nanograms per deciliter (ng/dL).
Measured: At Months 18 and 24
Sub-study: Number of Participants With Treatment-emergent Adverse Events
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and it does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose in sub-study.
Measured: From 1st dose of study intervention (relugolix on Day -14) up to end of sub-study (Day 28)

Timeline

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

19 Aug 202025 Oct 2023

First posted21 Aug 2020
Study start19 Aug 2020
Primary completion23 Oct 2023
Study completion25 Oct 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 Prostatic NeoplasmsStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04523207
Sponsor's protocol ID: CR108875
Other IDs: 56021927PCR2041
Status last verified: Apr 2026
First submitted: 20 Aug 2020
Last updated: 21 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

Shore N, Hafron J, Saltzstein D, Brown G, Belkoff L, Aggarwal P, Phillips J, Bhaumik A, McGowan T. Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP). J Urol. 2024 Nov;212(5):682-691. doi: 10.1097/JU.0000000000004163. Epub 2024 Aug 1.
PubMed 39088398
Brown G, Belkoff L, Hafron JM, Saltzstein DR, Potdar R, Bhaumik A, Phillips J, McGowan T, Shore ND. Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases. Target Oncol. 2023 Jan;18(1):95-103. doi: 10.1007/s11523-022-00932-8. Epub 2022 Dec 6.
PubMed 36472728

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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
ClinicalTrials.gov ID: NCT04523207
Acronym / sponsor ID: CR108875
Conditions: Prostatic Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 19 Aug 2020 (actual)
Primary completion: 23 Oct 2023 (actual)
Study completion: 25 Oct 2023 (actual)
First posted: 21 Aug 2020 (actual)
Results: Posted 19 Nov 2024

Clinical summary

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

Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Apalutamide + Androgen Deprivation Therapy (ADT)	Experimental	Drug: Apalutamide, Drug: ADT, Drug: RelugolixIn the main study, participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days). Participants who enrolled in the sub-study will receive apalutamide 240 mg once daily along with relugolix (a type of ADT) 120 mg once daily following a loading dose of 360 mg relugolix orally. Sub-study participants will be receiving relugolix up to Day 28 after which they will be transitioned into the main study from Cycle 2 Day 1 and will continue to receive conventional or oral ADT.

Who may qualify

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

Key inclusion criteria (5 listed)

A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of <= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer
Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator
Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician
Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1
Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (>=) 20 ng/ml or; Gleason Score >= 9 in any core on biopsy or; Gleason Score >= 8 (4+4 or 5+3) in greater than (>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy

Key exclusion criteria (5 listed)

History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (<) 2 centimeter (cm) in diameter [short axis] either radiographically or pathologically are allowed.)
History of bilateral orchiectomy
Received an investigational intervention <= 4 weeks before the planned first dose of study intervention
History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)

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
ApalutamideAlso: JNJ-56021927Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.	Drug	Apalutamide + Androgen Deprivation Therapy (ADT)
ADTParticipants will receive ADT intramuscular or subcutaneously during the main study.	Drug	Apalutamide + Androgen Deprivation Therapy (ADT)
RelugolixParticipants will receive 120 mg of relugolix following a loading dose of 360 mg of (3 tablets of 120 mg each) relugolix during the sub-study.	Drug	Apalutamide + Androgen Deprivation Therapy (ADT)

Primary outcome

Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24
Time frame: At Month 24
Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/mL). Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA > 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study.
Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28
Time frame: From Day -14 through Day 28
Percentage of participants maintaining testosterone level <50 ng/dL through Day 28 were reported.

3 secondary outcomes

Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12
Time frame: At Month 12
Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24
Time frame: At Months 18 and 24
Sub-study: Number of Participants With Treatment-emergent Adverse Events
Time frame: From 1st dose of study intervention (relugolix on Day -14) up to end of sub-study (Day 28)

Results and safety

Results posted to the registry on 19 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main Study: Apalutamide Plus Androgen Deprivation Therapy (ADT)	96	78
Sub Study: Relugolix Followed by Apalutamide Plus Relugolix	12	9

Primary outcome: Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24

Time frame: At Month 24. Number (90% Confidence Interval). Unit: Percentage of participants

Measure	Apalutamide Plus ADT (Main Study) + Relugolix Followed by Apalutamide Plus Relugolix (Sub Study) n = 108
Value	100 (93.4 to 100)

Population analysed: Modified intent-to-treat (MITT) analysis set included all participants who were enrolled in the study, received at least 1 dose of apalutamide, and had a baseline prostate-specific antigen (PSA) and at least 1 post-treatment PSA assessment. Data for this outcome measures was planned to be collected and analyzed for combined population of main study and sub-study (after the participants transitioned into main study).

Primary outcome: Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28

Time frame: From Day -14 through Day 28. Number. Unit: Percentage of participants

Measure	Sub Study: Relugolix Followed by Apalutamide Plus Relugolix n = 11
Value	100

Population analysed: MITT analysis set included all participants were enrolled in the study, received at least 1 dose of apalutamide, and had a baseline PSA and at least 1 post-treatment PSA assessment. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for main study.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Main study and sub-study combined: From first dose of study drug (Cycle 1 Day 1 for main study and Cycle 2 Day 1 for sub-study [post transition into main study]) up to end of study (Month 36); sub-study alone: From Day -14 up to end of sub-study treatment (Day 28). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Study Plus Sub-study (Post Transition)	16 of 108 (14.8%)	107 of 108 (99.1%)	0 of 108
Sub Study Alone (Before Transition)	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39088398Shore N, Hafron J, Saltzstein D, Brown G, Belkoff L, Aggarwal P, Phillips J, Bhaumik A, McGowan T. Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP). J Urol. 2024 Nov;212(5):682-691. doi: 10.1097/JU.0000000000004163. Epub 2024 Aug 1.
Derived from this study: PubMed 36472728Brown G, Belkoff L, Hafron JM, Saltzstein DR, Potdar R, Bhaumik A, Phillips J, McGowan T, Shore ND. Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases. Target Oncol. 2023 Jan;18(1):95-103. doi: 10.1007/s11523-022-00932-8. Epub 2022 Dec 6.
Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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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.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

32 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, ADT and Relugolix in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 32 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 5 inclusion and 5 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 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 19 Nov 2024). 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?

Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24 (time frame: At Month 24). The study lists 2 primary outcomes in all. 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 NCT04523207, 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 21 Apr 2026.