NCT02903160

Brief Summary

The purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management of castration resistant prostate cancer. The hypothesis is that the identification of optimal combinations and sequencing of therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2017

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 13, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 7, 2024

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

4.8 years

First QC Date

September 7, 2016

Results QC Date

December 1, 2023

Last Update Submit

January 16, 2024

Conditions

Prostate Cancer

Keywords

Castration resistantProstate cancerMetastaticFirst-lineTreatment naiveRapidly cyclingNon-cross resistant

Outcome Measures

Primary Outcomes (1)

  • Time to Disease Progression

    Time to disease progression, as determined by either PSA or radiographic progression, after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with mCRPC. Time to progression (TTP) is defined as beginning with the time the first dose of PCD regimen is administered until disease progression.

    47.8 months

Secondary Outcomes (7)

  • Overall Survival (OS)

    47.8 months

  • Overall Rate of Survival

    40 months

  • Number of Participants With PSA Response Rate >90%

    up to 36 weeks

  • Number of Participants With PSA Response Rate >=50%

    up to 36 weeks

  • Number of Participants With PSA Progression Compared to Baseline.

    up to 36 weeks

  • +2 more secondary outcomes

Study Arms (1)

Intensive, Non-Cross Reactive Therapy

EXPERIMENTAL

Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate; 2. Cabazitaxel + Carboplatin; 3. Enzalutamide + Radium-223

Drug: Abiraterone acetateDrug: PrednisoneDrug: Radium-223 dichlorideDrug: cabazitaxelDrug: CarboplatinDrug: Enzalutamide

Interventions

Abiraterone acetateDRUG

Abiraterone acetate 1000 mg PO daily

Intensive, Non-Cross Reactive Therapy
PrednisoneDRUG

5 mg PO twice a day

Intensive, Non-Cross Reactive Therapy
Radium-223 dichlorideDRUG

50 kBq/kg IV monthly

Intensive, Non-Cross Reactive Therapy
cabazitaxelDRUG

25 mg/m2 IV every 3 weeks

Intensive, Non-Cross Reactive Therapy
CarboplatinDRUG

Carboplatin AUC 4 IV every 3 weeks

Intensive, Non-Cross Reactive Therapy
EnzalutamideDRUG

160 mg PO daily

Intensive, Non-Cross Reactive Therapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic castrate resistant prostate cancer, defined by progressive disease based on either rising PSA, new bone metastases, or progression of measurable disease on standard imaging, according to PCWG2 guidelines, despite androgen deprivation therapy
  • Ongoing androgen deprivation therapy with a GnRH analogue, GnRH antagonist, or bilateral orchiectomy
  • ECOG performance status 0-1
  • Serum testosterone level \< 50 ng/dL
  • Absolute neutrophil count \> 1,500/μL, platelet count \> 100,000/μL, and hemoglobin \> 9 g/dL
  • Creatinine \< 2 mg/dL
  • Total bilirubin \< 1 times the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal

You may not qualify if:

  • History of uncontrolled seizure disorder
  • Clinically significant cardiovascular disease including:
  • Myocardial infarction or uncontrolled angina within 6 months
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past
  • Uncontrolled hypertension as indicated by a resting systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 105 mmHg at the screening visit
  • Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval
  • Major surgery within 4 weeks of enrollment
  • Radiation therapy within 4 weeks of enrollment
  • Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease
  • Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed ≥ 4 weeks prior to enrollment
  • Prior sipuleucel-T use is allowed, but must be completed ≥ 4 weeks prior to enrollment
  • Concurrent use of zoledronic acid or denosumab is allowed on study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Beth Israel

New York, New York, 10011, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

Abiraterone AcetatePrednisoneradium Ra 223 dichloridecabazitaxelCarboplatinenzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesPregnanesCoordination ComplexesOrganic Chemicals

Results Point of Contact

Title
Dr. Bobby Liaw
Organization
Icahn School of Medicine at Mount Sinai
bobby.liaw@mountsinai.org
212-604-6010

Study Officials

  • Bobby Liaw, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Profesor

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 16, 2016

Study Start

January 13, 2017

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

February 7, 2024

Results First Posted

February 7, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)