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.

NCT06274047 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2023-0409NCI-2024-01553
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

1. 1.Personalize treatment for prostate cancer based on how aggressive the disease is and
2. 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.

Conditions

Androgen Axis Suppression; Prostatectomy; Prostate Cancer

Keywords

Prostate; Salvage Radiation; ADT; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year.

Study Arms (4)

Arm 1

EXPERIMENTAL

Participants will receive 6 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.

Drug: Androgen Deprivation Therapy

Arm 2

EXPERIMENTAL

Participants will receive 6 months of apalutamide and radiation therapy.

Drug: Apalutamide

Arm 3

EXPERIMENTAL

Participants will receive 24 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.

Drug: Androgen Deprivation Therapy

Arm 4

EXPERIMENTAL

Participants will receive 6 months of ADT, apalutamide, and radiation therapy.

Drug: Apalutamide; Drug: Androgen Deprivation Therapy

Interventions

Apalutamide DRUG

Given by PO

Arm 2; Arm 4

Androgen Deprivation Therapy DRUG

Given by PO

Also known as: ADT

Arm 1; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Confirmed extrapelvic or bone disease
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40645505 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Karen Hoffman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Hoffman, MD

CONTACT

(713) 563-2339; khoffman1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 23, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (3)