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.

Part of paid clinical trials in Chicago, Illinois.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06274047
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    Given by PO
  • Androgen Deprivation Therapy — DRUG
    Given by PO

Study Details

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.

Key Dates

Start date
Sep 10, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants will receive 6 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
  • Experimental: Arm 2
    Participants will receive 6 months of apalutamide and radiation therapy.
  • Experimental: Arm 3
    Participants will receive 24 months of standard-of-care androgen deprivation therapy (ADT) and radiation therapy.
  • Experimental: Arm 4
    Participants will receive 6 months of ADT, apalutamide, and radiation therapy.

Primary Outcome Measure

Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Rush MD AndersonChicagoIllinois60607
Dian Wang, MD
[email protected]
Dian Wang, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66103
Xinglei Shen, MD
[email protected]
Xinglei Shen, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Paul Nguyen, MD
[email protected]
Paul Nguyen, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Marisa Kollmeier, MD
[email protected]
Marisa Kollmeier, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Karen Hoffman, MD
[email protected]
713-563-2339
Karen Hoffman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Rush MD Anderson· Chicago, ILUniversity of Kansas Medical Center· Kansas City, KSDana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYMD Anderson Cancer Center· Houston, TX

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