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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.

StatusRecruiting
PhasePhase 3
Started2024-09-10
View on ClinicalTrials.gov ↗

Amendment history

2026-07-21
Study Status, Contacts/Locations v12
Study sites5→6
2026-06-24
Study Status, Eligibility v11
Eligibility criteria+288 characters
[...] ) 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 o [...] History of any of the following: Seizure or known condition [...] of the investigational regimen are eligible for this trial. Confirmed8) extrapelvic or bone disease Medications known to lower the seizure threshold (listed in [...]
2026-05-18
Study Status, Contacts/Locations v10
Study sites3→5
2026-04-21
Study Status v9
Re-verified, no change to tracked fields
2025-10-29
Study Status, Contacts/Locations v8
Study sites2→3
Show 7 earlier versions
2025-10-13
Study Status, Contacts/Locations v7
Study sites1→2
2025-05-14
Study Status v6
Re-verified, no change to tracked fields
2024-11-07
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v5
Study sitescontacts updated at 1 of 1 site
Study titlerevised
[...] tion to Improve Quality of Life in Post-Operative Radiation withWith Androgen Axis Suppression. aA Phase III Multi-center Study for Men withWith Detectable PSA After Prostatectomy for Prostate Cancer.
2024-09-25
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-08-31→confirmed 2024-09-10
Study sitesdetails revised at 1 of 1 site
Study titlerevised
[...] tion to Improve Quality of Life in Post-Operative Radiation Withwith Androgen Axis Suppression. Aa Phase III Multi-center Study for Men Withwith Detectable PSA After Prostatectomy for Prostate Cancer.
2024-03-26
Study Status v3
Re-verified, no change to tracked fields
2024-03-01
Study Status, Outcome Measures v2
Primary endpoints1 entry, revised
SafetyFunctional andAssessment adverseof eventsChronic Illness Therapy-Fatigue Scale (AEsFACIT-Fatigue)
2024-02-27
Study Status, Study Description, Conditions, Eligibility v1
Eligibility criteriarevised
[...] igible for this trial. Confirmed extrapelvic or bone disease ⇅ moved 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.
Study description+256 characters
Primary Objective: ARTERA LOW COHORT (less aggressive disease) 1) 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) 1) To compare fatigue at 24 months, as assessed by FACIT-fat [...]
2024-02-16
Original filing
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.
Trial Details
NCT Number NCT06274047
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Janssen Scientific Affairs, LLC
Conditions Androgen Axis Suppression, Prostatectomy, Prostate Cancer
Enrollment 120 participants
Start Date 2024-09-10
Primary Completion 2027-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-22