Prostate CancerPhase 2NCT02742675
Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)
A Phase 2 study testing Bicalutamide, goserelin acetate and flutamide in people with Prostate Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Bicalutamide, goserelin acetate and flutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients;
- 18 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: OMPCa-Shanghai: An Open-label, Randomized Prospective Phase II Trial of Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Oligometastatic Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Bicalutamide, goserelin acetate, flutamide, leuprolide acetate, triptorelin
- Keywords
- prostate cancer, androgen deprivation therapy, local treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Casodex
Given orally
goserelin acetateDrug
Also called Zoladex
Given subcutaneously or as an injection
flutamideDrug
Also called Eulexin
Given orally
leuprolide acetateDrug
Also called Enantone
Given subcutaneously or as an injection
triptorelinDrug
Also called Diphereline
Given subcutaneously or as an injection
Definitive TreatmentProcedure or surgery
surgery to remove prostate or radiation therapy to the prostate.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Bicalutamide; Drug: goserelin acetate; Drug: flutamide; Drug: leuprolide acetate; Drug: 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. Receives: Drug: Bicalutamide; Drug: goserelin acetate; Drug: flutamide; Drug: leuprolide acetate; Drug: triptorelin; Procedure: Definitive Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (radiographic progression-free survival)
Measured: 2 years
Secondary outcomes (3)
Overall survival
Measured: 3 years
time of PSA progression
Measured: 3 years
the quality of life
Quality of Life assessed by the EORTC QLQ-C30 questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2021 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
- Investigators
- Ye Dingwei, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742675
- Sponsor's protocol ID
- FUSCC-OMPCa
- Status last verified
- Jul 2020
- First submitted
- 11 Apr 2016
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35780048
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OMPCa-Shanghai: An Open-label, Randomized Prospective Phase II Trial of Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Oligometastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT02742675
- Acronym / sponsor ID
- FUSCC-OMPCa
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, androgen deprivation therapy, local treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| androgen deprivation therapy | Experimental | Drug: Bicalutamide, Drug: goserelin acetate, Drug: flutamide, Drug: leuprolide acetate, Drug: triptorelinPatients 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). |
| androgen deprivation therapy plus definitive treatment | Experimental | Drug: Bicalutamide, Drug: goserelin acetate, Drug: flutamide, Drug: leuprolide acetate, Drug: triptorelin, Procedure: Definitive TreatmentPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male patients;
- 18 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BicalutamideAlso: CasodexGiven orally | Drug | androgen deprivation therapy, androgen deprivation therapy plus definitive treatment |
| goserelin acetateAlso: ZoladexGiven subcutaneously or as an injection | Drug | androgen deprivation therapy, androgen deprivation therapy plus definitive treatment |
| flutamideAlso: EulexinGiven orally | Drug | androgen deprivation therapy, androgen deprivation therapy plus definitive treatment |
| leuprolide acetateAlso: EnantoneGiven subcutaneously or as an injection | Drug | androgen deprivation therapy, androgen deprivation therapy plus definitive treatment |
| triptorelinAlso: DipherelineGiven subcutaneously or as an injection | Drug | androgen deprivation therapy, androgen deprivation therapy plus definitive treatment |
| Definitive Treatmentsurgery to remove prostate or radiation therapy to the prostate. | Procedure or surgery | androgen deprivation therapy plus definitive treatment |
Primary outcome
Progression-Free Survival (radiographic progression-free survival)
Time frame: 2 years
3 secondary outcomes
Overall survival
Time frame: 3 years
time of PSA progression
Time frame: 3 years
the quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 35780048Dai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Dingwei, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicalutamide, goserelin acetate and flutamide in people with Prostate Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (radiographic progression-free survival) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.