NCT02742675

Brief Summary

The goal of this clinical research is to learn if treatment with androgen deprivation therapy in combination with surgery or radiation therapy can prolong the progression-free survival of oligometastatic prostate cancer than androgen deprivation therapy alone. The safety of this treatment combination will also be studied.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

5.5 years

First QC Date

April 11, 2016

Last Update Submit

July 5, 2020

Conditions

Prostate Cancer

Keywords

prostate cancerandrogen deprivation therapylocal treatment

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (radiographic progression-free survival)

    2 years

Secondary Outcomes (3)

  • Overall survival

    3 years

  • time of PSA progression

    3 years

  • the quality of life

    3 years

Study Arms (2)

androgen deprivation therapy

EXPERIMENTAL

Patients will receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide acetate, goserelin acetate, buserelin, or triptorelin) subcutaneously or as an injection AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily).

Drug: BicalutamideDrug: goserelin acetateDrug: flutamideDrug: leuprolide acetateDrug: triptorelin

androgen deprivation therapy plus definitive treatment

EXPERIMENTAL

Patients will receive androgen-deprivation therapy as in arm I in addition to definitive treatment including surgery to remove prostate or radiation therapy to the prostate.

Drug: BicalutamideDrug: goserelin acetateDrug: flutamideDrug: leuprolide acetateDrug: triptorelinProcedure: Definitive Treatment

Interventions

BicalutamideDRUG

Given orally

Also known as: Casodex
androgen deprivation therapyandrogen deprivation therapy plus definitive treatment
goserelin acetateDRUG

Given subcutaneously or as an injection

Also known as: Zoladex
androgen deprivation therapyandrogen deprivation therapy plus definitive treatment
flutamideDRUG

Given orally

Also known as: Eulexin
androgen deprivation therapyandrogen deprivation therapy plus definitive treatment
leuprolide acetateDRUG

Given subcutaneously or as an injection

Also known as: Enantone
androgen deprivation therapyandrogen deprivation therapy plus definitive treatment
triptorelinDRUG

Given subcutaneously or as an injection

Also known as: Diphereline
androgen deprivation therapyandrogen deprivation therapy plus definitive treatment
Definitive TreatmentPROCEDURE

surgery to remove prostate or radiation therapy to the prostate.

androgen deprivation therapy plus definitive treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients;
  • yrs and older, and 80 yrs and younger;
  • Histologically or cytologically proven prostate carcinoma;
  • Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI; and metastatic lesions are limited to the lymph nodes or bones, at the same time the number of lesions should less than or equal to 5;
  • ECOG PS 0 or 1;
  • Treatment initiation with androgen deprivation therapy no longer than 6 months prior to randomization;
  • Life-expectancy based on comorbid conditions \>2 years;
  • No serious medical complications;
  • The primary lesion of prostate cancer has not yet received local treatment;
  • Must be a candidate for surgery and/or radiation therapy and follow-up and the treatment will not bring about serious complications to patients;
  • Ability to understand and willingness to sign informed consent.

You may not qualify if:

  • Had received treatment for primary lesion, including: radical prostatectomy, radical radiation therapy and so on;
  • Patients who received systemic chemotherapy before;
  • Androgen deprivation therapy time is greater than six months;
  • Visceral organ metastasis (liver, lung, brain and other organs);
  • Small cell carcinoma of the prostate;
  • Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely;
  • Patients who are not willing to accept the complications caused by the treatment to primary lesion;
  • Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years);
  • Other serious diseases, for example: unstable heart disease after treatment, myocardial infarction in 6 months prior to treatment, cardiac function grade 3-4 (NYHA); high blood pressure that can not be controlled after medical treatment (greater than 150/90mmHg); serious neurological or mental disorders, including dementia and epilepsy; uncontrolled active infection; acute gastric ulcer; hypocalcemia; chronic obstructive pulmonary disease that needs hospital treatment;
  • Has participated in other clinical research before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Dai B, Zhang S, Wan FN, Wang HK, Zhang JY, Wang QF, Kong YY, Ma XJ, Mo M, Zhu Y, Qin XJ, Lin GW, Ye DW. Combination of Androgen Deprivation Therapy with Radical Local Therapy Versus Androgen Deprivation Therapy Alone for Newly Diagnosed Oligometastatic Prostate Cancer: A Phase II Randomized Controlled Trial. Eur Urol Oncol. 2022 Oct;5(5):519-525. doi: 10.1016/j.euo.2022.06.001. Epub 2022 Jun 29.

    PMID: 35780048DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamideGoserelinFlutamideLeuprolideTriptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ye Dingwei, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 19, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2021

Study Completion

March 1, 2023

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)