Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03436654
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    240mg daily orally
  • Abiraterone Acetate — DRUG
    1000mg daily orally
  • Prednisone — DRUG
    5mg BID orally
  • GnRH agonist/antagonist — DRUG
    Physician's choice, for a total duration not to extend beyond the treatment phase of the protocol or 10 months from the start of investigational agent(s)

Study Details

The purpose of this study is to test if treatment with medications that reduce the male hormone level in the participant's body for a few months before surgery can shrink prostate cancer as much as possible, which might reduce the chances of the cancer coming back in the future. These treatments include a hormone injection given monthly or every three months and the study drugs, which include abiraterone acetate, prednisone, and apalutamide. These medications are being used in combination with surgery and maybe radiotherapy because studies have shown that any single approach on its own is not sufficient to control or get rid of the cancer especially if they have high risk or aggressive features. The researchers hope to learn if combining the study drugs with surgery and radiation will get rid of the cancer from participants' prostates and reduce their prostate-specific antigen (PSA) to an undetectable level.

Key Dates

Start date
Jun 21, 2018
Status verified
Apr 2026
Primary completion
Mar 16, 2026
Completion
Feb 14, 2027

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A, Treatment 1 (ADT + Apalutamide Only)
  • Experimental: Cohort A, Treatment 2 (ADT + Apalutamide + Abiraterone Acetate + Prednisone)
    This arm is no longer being assigned to subjects.
  • Experimental: Cohort B1, Treatment 1 (ADT + Apalutamide Only)
  • Experimental: Cohort B1, Treatment 2 (ADT + Apalutamide + Abiraterone Acetate + Prednisone)
  • Experimental: Cohort B2, Treatment 1 (ADT + Apalutamide Only)
  • Experimental: Cohort B2, Treatment 2 (ADT + Apalutamide + Abiraterone Acetate + Prednisone)
  • Experimental: B2 Expansion, Treatment 1 (ADT + Apalutamide Only)

Primary Outcome Measure

Pathologic Response (pCR + MRD) in the RP specimen [ Time Frame: 6 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Northwestern UniversityEvanstonIllinois60208-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553-
Cleveland ClinicClevelandOhio44195-

Find similar trials in Chicago, IL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Chicago· Chicago, ILNorthwestern University· Evanston, ILDana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJ

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