Prostate CancerPKUFH-GS5NCT06864533
Adjuvant Chemotherapy for High Malignant Prostate Cancer
An observational study of Prostate Cancer and Radiation Therapy, run by Peking University First Hospital at 3 sites in China.
Trial summary
This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Radiation Therapy, Chemotherapy
- What is being tested?
- Docetaxel
- Type of treatment
- Injection or infusion
- How many people
- 315 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2019to 1 Sep 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Patients who was histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components with no evidence of distant metastasis.
Who may be able to join
- Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components.
- No evidence of distant metastasis confirmed by imaging.
- Expected to receive standard radical treatment or postoperative radiotherapy.
- Estimated survival time greater than 12 months.
- Aged ≥ 18 years.
- Karnofsky Performance Status (KPS) ≥ 80.
- Adequate blood count: white blood cell ≥ 3.5 × 10^9/L, neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100.0 × 10^
Who cannot join
- History of malignant tumors (except those cured for more than 5 years).
- Previous abdominal radiation therapy.
- Weight loss > 10% within the past 6 months.
- Pre-existing or concomitant bleeding disorders.
- Active infections.
- Significant cardiovascular disease (e.g., controlled hypertension, unstable angina, NYHA class ≥ II congestive heart failure, unstable symptomatic arrhythmias, or ≥ II peripheral vascular disease) or any condition deemed intolerable to chemotherapy by the oncology department.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hebei Yi Zhou Cancer Hospital
Baoding, Hebei
Chao Liu, +86 15515526951, liuchao30602@126.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Mingwei Ma, +86-15810160120, dr.mingweima@stu.pku.edu.cn
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Yajie Liu, +86 13693556512, 13693556512@163.com
About this study
Official title: Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial
This study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.
- Conditions
- Prostate Cancer, Radiation Therapy, Chemotherapy, Gleason Score
- Being tested
- Docetaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called carboplatin
Chemotherapy will start 4-8 weeks after the completion of radiotherapy. The chemotherapy regimen will consist of docetaxel 75 mg/m² administered intravenously on Day 1, repeated every 21 days for a total of 4-6 cycles. In cases of significant neuroendocrine differentiation and if well-tolerated, a combination of docetaxel and carboplatin (docetaxel 75 mg/m² and carboplatin AUC 4-6) will be used. Pre-treatment with dexamethasone will be administered to reduce potential side effects.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Plus Chemotherapy Group | This group will receive the standard radical treatment as in Arm 2, followed by adjuvant chemotherapy with docetaxel. Chemotherapy will start 4-8 weeks after the completion of radiotherapy. The chemotherapy regimen will consist of docetaxel 75 mg/m² administered intravenously on Day 1, repeated every 21 days for a total of 4-6 cycles. In cases of significant neuroendocrine differentiation and if well-tolerated, a combination of docetaxel and carboplatin (docetaxel 75 mg/m² and carboplatin AUC 4-6) will be used. Pre-treatment with dexamethasone will be administered to reduce potential side effects. Receives: Drug: Docetaxel | |
| Standard Treatment Group | This group will receive the standard radical treatment for high-grade localized prostate cancer. Patients will undergo definitive or post operative radiotherapy. Endocrine therapy will be provided for high-risk patients as per NCCN guidelines, with a duration of 2 to 3 years with definitive radiotherapy . For postoperative patients, endocrine therapy will be given for salvage setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-Free Survivall，FFS
The time from radiotherapy to the first occurrence of any of the following events: biochemical recurrence, systemic treatment modification due to confirmed consecutive PSA elevation, radiographic distant metastasis, or death from any cause, whichever occurred first.
Measured: 5 years
Secondary outcomes (4)
Biochemical relapse-free survival，BRFS
The time from radiotherapy to the first occurrence of biochemical relapse (defined as PSA rise meeting the criteria for biochemical recurrence)
Measured: 5 years
Metastasis-free survival, MFS
The time from radiotherapy to the first occurrence of distant metastasis.
Measured: 5 years
Overall survival, OS
The time from radiotherapy to the first occurrence of death.
Measured: 5 years
Toxicities
The assessment of adverse events will be conducted using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Sep 2019
- Primary completion1 Sep 2025
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864533
- Sponsor's protocol ID
- PKUFH-GS5
- Acronym
- PKUFH-GS5
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chemotherapy With Adjuvant Docetaxel After Radiotherapy for Localized High Malignant Prostate Cancer: A Prospective Muti-center Non-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06864533
- Acronym / sponsor ID
- PKUFH-GS5 / PKUFH-GS5
- Conditions
- Prostate Cancer, Radiation Therapy, Chemotherapy, Gleason Score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University Shenzhen Hospital
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 7 Mar 2025 (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 study aims to evaluate the efficacy of adjuvant docetaxel chemotherapy following radical radiotherapy in patients with localized high-grade prostate cancer. Eligible participants include those diagnosed with prostate cancer confirmed by biopsy or surgical pathology, with a Gleason score of 9-10 or containing a Gleason 5 component, and no evidence of distant metastasis. Patients will be divided into two groups: the standard treatment group receiving only radical treatment (radiotherapy or surgery), and the standard treatment plus chemotherapy group, receiving four to six cycles of docetaxel chemotherapy after standard treatment. The primary endpoint is Failure-Free Survival (FFS), with secondary endpoints including Biochemical Relapse-Free Survival (BRFS), Metastasis-Free Survival (MFS), Overall Survival (OS), and assessment of adverse events The study aims to better understand the impact of adjuvant chemotherapy on the prognosis of patients with high-risk prostate cancer and determine whether it improves survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Plus Chemotherapy Group | – | Drug: DocetaxelThis group will receive the standard radical treatment as in Arm 2, followed by adjuvant chemotherapy with docetaxel. Chemotherapy will start 4-8 weeks after the completion of radiotherapy. The chemotherapy regimen will consist of docetaxel 75 mg/m² administered intravenously on Day 1, repeated every 21 days for a total of 4-6 cycles. In cases of significant neuroendocrine differentiation and if well-tolerated, a combination of docetaxel and carboplatin (docetaxel 75 mg/m² and carboplatin AUC 4-6) will be used. Pre-treatment with dexamethasone will be administered to reduce potential side effects. |
| Standard Treatment Group | – | –This group will receive the standard radical treatment for high-grade localized prostate cancer. Patients will undergo definitive or post operative radiotherapy. Endocrine therapy will be provided for high-risk patients as per NCCN guidelines, with a duration of 2 to 3 years with definitive radiotherapy . For postoperative patients, endocrine therapy will be given for salvage setting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who was histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components with no evidence of distant metastasis.
Key inclusion criteria (7 listed)
- Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components.
- No evidence of distant metastasis confirmed by imaging.
- Expected to receive standard radical treatment or postoperative radiotherapy.
- Estimated survival time greater than 12 months.
- Aged ≥ 18 years.
Key exclusion criteria (6 listed)
- History of malignant tumors (except those cured for more than 5 years).
- Previous abdominal radiation therapy.
- Weight loss > 10% within the past 6 months.
- Pre-existing or concomitant bleeding disorders.
- Active infections.
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 |
|---|---|---|
| DocetaxelAlso: carboplatinChemotherapy will start 4-8 weeks after the completion of radiotherapy. The chemotherapy regimen will consist of docetaxel 75 mg/m² administered intravenously on Day 1, repeated every 21 days for a total of 4-6 cycles. In cases of significant neuroendocrine differentiation and if well-tolerated, a combination of docetaxel and carboplatin (docetaxel 75 mg/m² and carboplatin AUC 4-6) will be used. Pre-treatment with dexamethasone will be administered to reduce potential side effects. | Drug | Standard Treatment Plus Chemotherapy Group |
Primary outcome
Failure-Free Survivall，FFS
Time frame: 5 years
The time from radiotherapy to the first occurrence of any of the following events: biochemical recurrence, systemic treatment modification due to confirmed consecutive PSA elevation, radiographic distant metastasis, or death from any cause, whichever occurred first.
4 secondary outcomes
Biochemical relapse-free survival，BRFS
Time frame: 5 years
Metastasis-free survival, MFS
Time frame: 5 years
Overall survival, OS
Time frame: 5 years
Toxicities
Time frame: 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 20 Aug 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Radiation Therapy, run by Peking University First Hospital at 3 sites 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-Free Survivall，FFS (time frame: 5 years). 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 20 Aug 2026.