Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04262154
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg IV over 60 minutes every 3 weeks
  • Abiraterone — DRUG
    Abiraterone 1000 mg daily
  • Prednisone — DRUG
    Prednisone 5 mg daily
  • GnRH analog — DRUG
    Any GnRH analog that is commercially available, injectable, and long acting analog of the native LHRH peptide and is administered to subjects via intramuscular injection. For this study, any GnRH analog can be used and thee manufacturer's instructions for dose and frequency should be followed.
  • Stereotactic Body Radiotherapy (SBRT) — RADIATION
    Intensity-modulated, image-guided, ultra-hypofractionated external beam radiotherapy (7.25-7.5 Gy x 5 to prostate and seminal vesicles QOD) will begin around 12 weeks (at Cycle 5 Day 1 (+/-5 days)
  • Enzalutamide — DRUG
    160 mg once daily
  • Follow up — OTHER
    Subjects who discontinue study treatment for reasons other than progression will be followed every 6 months (+/- 4 weeks) until a documented progression event (i.e., PSA, radiographic, or clinical progression). After a documented progressionevent (whether on treatment or during follow up), subjects will continue to be followed every 6 months (+/- 4 weeks) for overall survival via chart review and/or telephone call.

Study Details

This study is to find out whether adding the study drug atezolizumab and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer, and to see whether the study treatment works better than the standard treatment.

Key Dates

Start date
Mar 3, 2020
Status verified
May 2026
Primary completion
Jul 7, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Metastatic Prostate Cancer
    Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer.Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.

Primary Outcome Measure

Failure-free Rate at 2 Years [ Time Frame: 2 years ]

Locations (8)

FacilityCityStateZIP
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 Cancer Commack (Limited Protocol Activities)CommackNew York11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Columbia UniversityNew YorkNew York10032
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553

Related coverage on Hipa.ai

Find similar trials in Basking Ridge, NJ

By research site
Memorial 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, NJMemorial Sloan Kettering Cancer Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYColumbia University· New York, NY

Related Studies