Androgen Axis SuppressionPhase 3NCT06274047

PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.

A Phase 3 study testing Apalutamide and Androgen Deprivation Therapy in people with Androgen Axis Suppression and Prostatectomy, run by M.D. Anderson Cancer Center at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

1. Personalize treatment for prostate cancer based on how aggressive the disease is and 2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Androgen Axis Suppression, Prostatectomy, Prostate Cancer
What is being tested?: Apalutamide and Androgen Deprivation Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 6 sitesUnited States
Study dates: 10 Sep 2024to 30 Jun 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 cancer.
PSA ≥ 0.1 after radical prostatectomy.
Candidate for salvage radiation and ADT treatment, as determined by treating physician.
Age >18 at the time of consent.
ECOG Performance Status ≤ 2.
Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 90 days of registration.

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System Laboratory Value
Hematological:
Platelet count (plt) = ≥ 100,000/µL
Hemoglobin (Hgb) = ≥ 9 g/dL
Renal:
eGFR = ≥ 30 mL/min using MDRD Formula
Hepatic and Other:
Bilirubin2 = ≤1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) = ≤ 2.5 x ULN Alanine aminotransferase (ALT) = ≤ 2.5 x ULN Serum Albumin = > 3.0 g/dL Serum potassium = ≥ 3.5 mmol/L 2In subjects with Gilbert's syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.
Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee.
Ability to understand English or Spanish language as determined by the site investigator or protocol designee. Since the primary outcome is a questionnaire available in English and Spanish.
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Participants must have the ability to understand and willingness to sign the written informed consent document.

Who cannot join

Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, participants with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone > 190 ng/dL) regardless of how long their testosterone was suppressed.
Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients with PSA ≤0.5 and no evidence of nodal involvement require ArteraAI Prostate Test (Post-RP) to stratify).
Confirmed extrapelvic or bone disease based on conventional imaging
History of any of the following:
Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization. Any condition that in the opinion of the investigator, would preclude participation in this study.

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Current evidence of any of the following:
Uncontrolled hypertension (consistently >160 systolic or >100 diastolic)
Gastrointestinal disorder affecting absorption
Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis).
Any condition that in the opinion of the investigator, would preclude participation in this study.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
8) Medications known to lower the seizure threshold (listed in section 5 below) must be discontinued or substituted 4 weeks prior to C1D1 of study treatment for participants on arms receiving apalutamide.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Karen Hoffman, MD contact

(713) 563-2339

khoffman1@mdanderson.org

City, postcode or hospital

Sites recruiting now only

6 sites in 1 country

United States6 sites, 6 recruiting

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Paul Nguyen, MD, paul_nguyen@dfci.harvard.edu
Paul Nguyen, MD
Recruiting
Rush MD Anderson
Chicago, Illinois, 60607
Dian Wang, MD, dian_wang@rush.edu
Dian Wang, MD
Recruiting
Banner MD Anderson
Gilbert, Arizona, 85234
Yerko Borghero, MD, yerko.borghero@bannerhealth.com
Yerko Borghero, MD
Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Karen Hoffman, MD, 713-563-2339, khoffman1@mdanderson.org
Karen Hoffman, MD
Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66103
Xinglei Shen, MD, xshen@kumc.edu
Xinglei Shen, MD
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Marisa Kollmeier, MD, kollmeim@mskcc.org
Marisa Kollmeier, MD
Recruiting

Other trials in United States

About this study

Personalize treatment for prostate cancer based on how aggressive the disease is and
Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.

Read the detailed description

Primary Objective:

ARTERA LOW COHORT (less aggressive disease)

To compare fatigue at 9 months, as assessed by FACIT-F, between participants assigned to six months of apalutamide monotherapy versus six months of GnRH-based ADT.

HIGHER RISK COHORT (more aggressive disease)

To compare fatigue at 24 months, as assessed by FACIT-fatigue, between participants assigned to six months of GnRH-based ADT plus apalutamide monotherapy versus 24 months of GnRH-based ADT.

Secondary Objectives for both Cohorts:

To compare patient-reported quality of life for the two treatment arms (Arm 1 vs. 2 for Artera-Low Cohort and Arm 3 vs. 4 for Artera-High Cohort) as measured by FACT-P and EPIC-26.
To compare physician-reported toxicity for the two treatment arms as measured by CTCAE v 5.
To compare patient-reported activity levels for the two treatment arms as measured by the leisure-time activity questionnaire.
To compare patient activity and sleep for the two treatment arms as measured by participant wearable health bands.
To compare cognitive function for the two treatment arms as measured by PROMIS-CF and the Symbol Digit Modality test.
To compare mental health for the two treatment arms as measured by the Health Anxiety and Depression Scale.
To compare changes in HgA1c and Lipid profiles over time between the two treatment arms.
To compare time to testosterone recovery between treatment arms.
To compare time to next therapy between treatment arms.
To compare progression-free survival, metastasis-free survival, cancer specific mortality and overall survival between treatment arms.
To compare risk of major acute coronary event between treatment arms.
In the subset of patients who agree to optional body composition measurements, to compare change in body composition including visceral fat and skeletal muscle mass between treatment arms.

Exploratory Objectives for both Cohorts:

In the subset of participants who agree to correlative studies, to evaluate the association between fatigue and circulating inflammatory cytokines.
In the subset of participants who agree to germline testing, to determine if inherited variants in steroidogenic genes influence individual body composition toxicity with androgen signaling inhibition.
To evaluate how germline variants interact with tumor intrinsic properties (via Artera) to determine the overall benefit patients derive from finite, intense androgen signaling inhibition in the post-operative setting.
To investigate the relationship between plasma exosomes, Artera tissue pattern, and the germline to somatic interaction.
To study the overlap between body composition toxicity and risk for coronary artery disease as measured by radiographic coronary calcifications and lab markers of coronary artery disease.
To evaluate the association between radiation plan metrics and patient-reported urinary and bowel functional changes.

Conditions: Androgen Axis Suppression, Prostatectomy, Prostate Cancer
Being tested: Apalutamide, Androgen Deprivation Therapy
Keywords: Prostate, Salvage Radiation, ADT, Quality of Life
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
Given by PO
Androgen Deprivation TherapyDrug
Also called ADT
Given by PO

Study groups in NCT06274047
Study group	Role	What they receive
Arm 1	Experimental	Participants will receive 6 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy. Receives: Drug: Androgen Deprivation Therapy
Arm 2	Experimental	Participants will receive 6 months of apalutamide and radiation therapy. Receives: Drug: Apalutamide
Arm 3	Experimental	Participants will receive 24 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy. Receives: Drug: Androgen Deprivation Therapy
Arm 4	Experimental	Participants will receive 6 months of ADT, apalutamide, and radiation therapy. Receives: Drug: Apalutamide; Drug: Androgen Deprivation Therapy

What is being measured

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

Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)
Score scale ranges (0-4) 0 - Not at all
1. - A little bit
2. - Somewhat
3. - Quite a bit
4. - Very Much
Measured: Through study completion; an average of 1 year.

Timeline

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

10 Sep 202430 Jun 2029

First posted23 Feb 2024
Study start10 Sep 2024
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Androgen Axis SuppressionStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06274047
Sponsor's protocol ID: 2023-0409
Other IDs: NCI-2024-01553
Status last verified: Jul 2026
First submitted: 16 Feb 2024
Last updated: 22 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Zamboglou C, Doncker W, Christoforou AT, Arcangeli S, Berlin A, Blanchard P, Bauman G, Campi R, Castro E, Choudhury A, Pra AD, Draulans C, Desai N, Ferentinos K, Francolini G, Gillessen S, Grosu AL, Rivas JG, Hoelscher T, Hruby G, Jereczek-Fossa BA, Kamran S, Kasivisvanathan V, Kishan AU, Kounnis V, Loblaw A, Martin J, Mastroleo F, Merseburger AS, Miszczyk M, Mohamad O, Ost P, Papatsoris A, Peeken JC, Sanguedolce F, Sargos P, Schmidt-Hegemann N, Seibert TM, Shelan M, Siva S, Soeterik TFW, Spratt DE, Stenzl A, Strouthos I, Sutera P, Supiot S, Tilki D, Tran PT, Tree AC, Tward J, Urun Y, Vapiwala N, Waddle MR, Wegener E, Zilli T, Murthy V, Thieme AH, Spohn S. oDigital pathology biomarkers for guiding radiotherapy-based treatment concepts in prostate cancer - a systematic review and expert consensus. Radiother Oncol. 2025 Sep;210:111039. doi: 10.1016/j.radonc.2025.111039. Epub 2025 Jul 9.
PubMed 40645505

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.
ClinicalTrials.gov ID: NCT06274047
Acronym / sponsor ID: 2023-0409
Conditions: Androgen Axis Suppression, Prostatectomy, Prostate Cancer
Keywords: Prostate, Salvage Radiation, ADT, Quality of Life
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: Janssen Scientific Affairs, LLC
Study start: 10 Sep 2024 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2029 (estimated)
First posted: 23 Feb 2024 (actual)
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.

Personalize treatment for prostate cancer based on how aggressive the disease is and
Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.

Detailed description

Primary Objective:

ARTERA LOW COHORT (less aggressive disease)

To compare fatigue at 9 months, as assessed by FACIT-F, between participants assigned to six months of apalutamide monotherapy versus six months of GnRH-based ADT.

HIGHER RISK COHORT (more aggressive disease)

To compare fatigue at 24 months, as assessed by FACIT-fatigue, between participants assigned to six months of GnRH-based ADT plus apalutamide monotherapy versus 24 months of GnRH-based ADT.

Secondary Objectives for both Cohorts:

To compare patient-reported quality of life for the two treatment arms (Arm 1 vs. 2 for Artera-Low Cohort and Arm 3 vs. 4 for Artera-High Cohort) as measured by FACT-P and EPIC-26.
To compare physician-reported toxicity for the two treatment arms as measured by CTCAE v 5.
To compare patient-reported activity levels for the two treatment arms as measured by the leisure-time activity questionnaire.
To compare patient activity and sleep for the two treatment arms as measured by participant wearable health bands.
To compare cognitive function for the two treatment arms as measured by PROMIS-CF and the Symbol Digit Modality test.
To compare mental health for the two treatment arms as measured by the Health Anxiety and Depression Scale.
To compare changes in HgA1c and Lipid profiles over time between the two treatment arms.
To compare time to testosterone recovery between treatment arms.
To compare time to next therapy between treatment arms.
To compare progression-free survival, metastasis-free survival, cancer specific mortality and overall survival between treatment arms.
To compare risk of major acute coronary event between treatment arms.
In the subset of patients who agree to optional body composition measurements, to compare change in body composition including visceral fat and skeletal muscle mass between treatment arms.

Exploratory Objectives for both Cohorts:

In the subset of participants who agree to correlative studies, to evaluate the association between fatigue and circulating inflammatory cytokines.
In the subset of participants who agree to germline testing, to determine if inherited variants in steroidogenic genes influence individual body composition toxicity with androgen signaling inhibition.
To evaluate how germline variants interact with tumor intrinsic properties (via Artera) to determine the overall benefit patients derive from finite, intense androgen signaling inhibition in the post-operative setting.
To investigate the relationship between plasma exosomes, Artera tissue pattern, and the germline to somatic interaction.
To study the overlap between body composition toxicity and risk for coronary artery disease as measured by radiographic coronary calcifications and lab markers of coronary artery disease.
To evaluate the association between radiation plan metrics and patient-reported urinary and bowel functional changes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm 1	Experimental	Drug: Androgen Deprivation TherapyParticipants will receive 6 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Arm 2	Experimental	Drug: ApalutamideParticipants will receive 6 months of apalutamide and radiation therapy.
Arm 3	Experimental	Drug: Androgen Deprivation TherapyParticipants will receive 24 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
Arm 4	Experimental	Drug: Apalutamide, Drug: Androgen Deprivation TherapyParticipants will receive 6 months of ADT, apalutamide, and radiation therapy.

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 cancer.
PSA ≥ 0.1 after radical prostatectomy.
Candidate for salvage radiation and ADT treatment, as determined by treating physician.
Age >18 at the time of consent.
ECOG Performance Status ≤ 2.

Key exclusion criteria (13 listed)

Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, participants with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone > 190 ng/dL) regardless of how long their testosterone was suppressed.
Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients with PSA ≤0.5 and no evidence of nodal involvement require ArteraAI Prostate Test (Post-RP) to stratify).
Confirmed extrapelvic or bone disease based on conventional imaging
History of any of the following:
Current evidence of any of the following:

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
ApalutamideGiven by PO	Drug	Arm 2, Arm 4
Androgen Deprivation TherapyAlso: ADTGiven by PO	Drug	Arm 1, Arm 3, Arm 4

Primary outcome

Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)
Time frame: Through study completion; an average of 1 year.
Score scale ranges (0-4) 0 - Not at all 1. - A little bit 2. - Somewhat 3. - Quite a bit 4. - Very Much

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Derived from this study: PubMed 40645505Zamboglou C, Doncker W, Christoforou AT, Arcangeli S, Berlin A, Blanchard P, Bauman G, Campi R, Castro E, Choudhury A, Pra AD, Draulans C, Desai N, Ferentinos K, Francolini G, Gillessen S, Grosu AL, Rivas JG, Hoelscher T, Hruby G, Jereczek-Fossa BA, Kamran S, Kasivisvanathan V, Kishan AU, Kounnis V, Loblaw A, Martin J, Mastroleo F, Merseburger AS, Miszczyk M, Mohamad O, Ost P, Papatsoris A, Peeken JC, Sanguedolce F, Sargos P, Schmidt-Hegemann N, Seibert TM, Shelan M, Siva S, Soeterik TFW, Spratt DE, Stenzl A, Strouthos I, Sutera P, Supiot S, Tilki D, Tran PT, Tree AC, Tward J, Urun Y, Vapiwala N, Waddle MR, Wegener E, Zilli T, Murthy V, Thieme AH, Spohn S. oDigital pathology biomarkers for guiding radiotherapy-based treatment concepts in prostate cancer - a systematic review and expert consensus. Radiother Oncol. 2025 Sep;210:111039. doi: 10.1016/j.radonc.2025.111039. Epub 2025 Jul 9.
MD Anderson Cancer CenterLink provided by the sponsor.

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.

Karen Hoffman, MD contact

(713) 563-2339

khoffman1@mdanderson.org

Karen Hoffman, MD principal investigator

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apalutamide and Androgen Deprivation Therapy in people with Androgen Axis Suppression and Prostatectomy, run by M.D. Anderson Cancer Center at 6 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 17 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karen Hoffman, MD ((713) 563-2339, khoffman1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) (time frame: Through study completion; an average of 1 year.). 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 NCT06274047, which also lists 1 linked publication.

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 22 Jul 2026.