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Status unknownNCT02742675Updated Jul 7, 2020

Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)

A Phase 2 interventional study of Bicalutamide and goserelin acetate in Prostate Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2015, registered Apr 2016).
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

Read the detailed description

Today androgen deprivation therapy has been a standard treatment for metastatic prostate cancer, but as to the special type of prostate cancer-oligometastatic prostate cancer, except for androgen deprivation therapy, whether local treatment can be the part of treatment for it? The purpose of this study is to evaluate whether local treatment combined with androgen deprivation therapy can extend progression-free survival, as well as overall survival and life quality of patients of oligometastatic prostate cancer compared with androgen deprivation therapy alone.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • prostate cancer
  • androgen deprivation therapy
  • local treatment
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 200 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Male patients;
  2. 18 yrs and older, and 80 yrs and younger;
  3. Histologically or cytologically proven prostate carcinoma;
  4. 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;
  5. ECOG PS 0 or 1;
  6. Treatment initiation with androgen deprivation therapy no longer than 6 months prior to randomization;
  7. Life-expectancy based on comorbid conditions >2 years;
  8. No serious medical complications;
  9. The primary lesion of prostate cancer has not yet received local treatment;
  10. Must be a candidate for surgery and/or radiation therapy and follow-up and the treatment will not bring about serious complications to patients;
  11. Ability to understand and willingness to sign informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Had received treatment for primary lesion, including: radical prostatectomy, radical radiation therapy and so on;
  2. Patients who received systemic chemotherapy before;
  3. Androgen deprivation therapy time is greater than six months;
  4. Visceral organ metastasis (liver, lung, brain and other organs);
  5. Small cell carcinoma of the prostate;
  6. Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely;
  7. Patients who are not willing to accept the complications caused by the treatment to primary lesion;
  8. 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);
  9. 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;
  10. Has participated in other clinical research before.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    androgen deprivation therapy

    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: Bicalutamide · Drug: goserelin acetate · Drug: flutamide · Drug: leuprolide acetate · Drug: triptorelin

  • Experimental
    androgen deprivation therapy plus definitive treatment

    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: Bicalutamide · Drug: goserelin acetate · Drug: flutamide · Drug: leuprolide acetate · Drug: triptorelin · Procedure: Definitive Treatment

Interventions

  • DrugBicalutamide

    Given orally

    Also known as: Casodex

  • Druggoserelin acetate

    Given subcutaneously or as an injection

    Also known as: Zoladex

  • Drugflutamide

    Given orally

    Also known as: Eulexin

  • Drugleuprolide acetate

    Given subcutaneously or as an injection

    Also known as: Enantone

  • Drugtriptorelin

    Given subcutaneously or as an injection

    Also known as: Diphereline

  • ProcedureDefinitive Treatment

    surgery to remove prostate or radiation therapy to the prostate.

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (radiographic progression-free survival)

    Time frame: 2 years

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

  2. time of PSA progression

    Time frame: 3 years

  3. the quality of life

    Quality of Life assessed by the EORTC QLQ-C30 questionnaire

    Time frame: 3 years

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02742675
Lead sponsor
Fudan University
Responsible party
Ding-Wei Ye (Principal Investigator, Fudan University) — Principal investigator
First posted
Apr 19, 2016
Start date
Sep 2015
Primary completion
Mar 2021 (estimated)
Completion
Mar 2023 (estimated)
Last update
Jul 7, 2020

Study contacts

Ye Dingwei, MD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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