Prostatic NeoplasmsNCT04093375
Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer
A study testing Radical Prostatectomy and Radical Radiotherapy in people with Prostatic Neoplasms, run by Tongji Hospital.
Trial summary
This prospective, open randomized clinical trial seeks to investigate whether radical prostatectomy with androgen deprivation therapy improves prostate-cancer specific survival and quality of life in comparison with radical radiation treatment with androgen deprivation therapy among patients diagnosed locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Radical Prostatectomy and Radical Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18≤Age ≤75, at the time of randomization.
- Confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated.
- Tumor stage (T, M, N): according to 2018 NCCN prostate cancer guidelines T3 stage Significant extra-capsular tumor extension M0 (no sign of distant metastases) Nx (regional lymph nodes cannot be assessed). For patients with T4, the tumor should be confined to the bladder neck, and bilateral ureters should not be invaded.
- WHO score 0-1, ECOG score 0-2, and ASA grade I-III.
- At least 5 years life expectancy.
- The general condition and mental status of patients shall permit observation in accordance with the study protocol.
- Signed Informed consent.
Who cannot join
- Concomitant with other malignancies.
- With severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy.
- Clinical significant abnormal laboratory values at the discretion of the investigator, e.g. severe kidney function GFR < 30 ml/ml or elevated liver transaminases above > 10 ULN.
- Involved in other clinical trials simultaneously.
- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
This prospective, open randomized clinical trial seeks to investigate whether radical prostatectomy with androgen deprivation therapy improves prostate-cancer specific survival and quality of life in comparison with radical radiation treatment with androgen deprivation therapy among patients diagnosed locally advanced prostate cancer. Lack of extensive PSA screening in mainland China, many new cases of prostate cancer are LAPCa. Surgery and/or radiation plus attempted chemotherapy are curative treatment for advanced solid malign tumors to control and eliminate the local and micro metastases. LAPCa is easy to metastasis, relapse and has a poor prognosis. For LAPCa, a single RP approach is generally not the preferred option because it is generally considered that radical surgery is difficult to completely remove the lesion and the long-term prognosis is not ideal. However, androgen deprivation therapy promotes the prognosis of LAPCa with lymph nodes or seminal vesicle metastases and improves the local control rate of tumor. What is more, for early localized prostate cancer, RT has similar efficacy to RP, for advanced tumor RT can not only relieve urinary tract obstruction and other symptoms, but also improve biochemical progression free survival and local oncological control. A randomized clinical trial comparing two multimodal treatment including RP or RT with ADT regimens is therefore warranted.
- Conditions
- Prostatic Neoplasms
- Being tested
- Radical Prostatectomy, Radical Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical ProstatectomyProcedure or surgery
Radical prostatectomy with or without androgen deprivation therapy
Radical RadiotherapyOther
Radical Radiotherapy with adjuvant androgen deprivation therapy
| Study group | Role | What they receive |
|---|---|---|
| Radical Prostatectomy | Experimental | Patients with locally advanced prostate adenocarcinoma receives Radical Prostatectomy with or without enlarged lymph node dissection Receives: Procedure: Radical Prostatectomy |
| Radical Radiotherapy | Active comparator | Patients with locally advanced prostate adenocarcinoma receives Radical Radiotherapy with adjuvant androgen deprivation therapy Receives: Other: Radical Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause-specific survival
Measured: Up to 5 years
Overall survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Zhejiang University, Sun Yat-sen University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Second Hospital
- Responsible party
- Sponsor
- Investigators
- Zhihua Wang, M.D ass. prof, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093375
- Sponsor's protocol ID
- 2019CR101
- Status last verified
- May 2019
- First submitted
- 16 Sep 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04093375
- Acronym / sponsor ID
- 2019CR101
- Conditions
- Prostatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Zhejiang University, Sun Yat-sen University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Second Hospital
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 2019 (actual)
- 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.
This prospective, open randomized clinical trial seeks to investigate whether radical prostatectomy with androgen deprivation therapy improves prostate-cancer specific survival and quality of life in comparison with radical radiation treatment with androgen deprivation therapy among patients diagnosed locally advanced prostate cancer. Lack of extensive PSA screening in mainland China, many new cases of prostate cancer are LAPCa. Surgery and/or radiation plus attempted chemotherapy are curative treatment for advanced solid malign tumors to control and eliminate the local and micro metastases. LAPCa is easy to metastasis, relapse and has a poor prognosis. For LAPCa, a single RP approach is generally not the preferred option because it is generally considered that radical surgery is difficult to completely remove the lesion and the long-term prognosis is not ideal. However, androgen deprivation therapy promotes the prognosis of LAPCa with lymph nodes or seminal vesicle metastases and improves the local control rate of tumor. What is more, for early localized prostate cancer, RT has similar efficacy to RP, for advanced tumor RT can not only relieve urinary tract obstruction and other symptoms, but also improve biochemical progression free survival and local oncological control. A randomized clinical trial comparing two multimodal treatment including RP or RT with ADT regimens is therefore warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical Prostatectomy | Experimental | Procedure: Radical ProstatectomyPatients with locally advanced prostate adenocarcinoma receives Radical Prostatectomy with or without enlarged lymph node dissection |
| Radical Radiotherapy | Active comparator | Other: Radical RadiotherapyPatients with locally advanced prostate adenocarcinoma receives Radical Radiotherapy with adjuvant androgen deprivation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18≤Age ≤75, at the time of randomization.
- Confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated.
- Tumor stage (T, M, N): according to 2018 NCCN prostate cancer guidelines T3 stage Significant extra-capsular tumor extension M0 (no sign of distant metastases) Nx (regional lymph nodes cannot be assessed). For patients with T4, the tumor should be confined to the bladder neck, and bilateral ureters should not be invaded.
- WHO score 0-1, ECOG score 0-2, and ASA grade I-III.
- At least 5 years life expectancy.
Key exclusion criteria (5 listed)
- Concomitant with other malignancies.
- With severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy.
- Clinical significant abnormal laboratory values at the discretion of the investigator, e.g. severe kidney function GFR < 30 ml/ml or elevated liver transaminases above > 10 ULN.
- Involved in other clinical trials simultaneously.
- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
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 |
|---|---|---|
| Radical ProstatectomyRadical prostatectomy with or without androgen deprivation therapy | Procedure or surgery | Radical Prostatectomy |
| Radical RadiotherapyRadical Radiotherapy with adjuvant androgen deprivation therapy | Other | Radical Radiotherapy |
Primary outcome
Cause-specific survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- 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.
Zhihua Wang, M.D ass. prof principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Radical Prostatectomy and Radical Radiotherapy in people with Prostatic Neoplasms, run by Tongji Hospital.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihua Wang, M.D ass. prof (8613607195518, zhwang_hust@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cause-specific survival (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2019.