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Could a chemo boost after radiation tame aggressive prostate cancer?

NCT ID NCT06864533

Disease control Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This trial is testing whether adding the chemotherapy drug docetaxel after standard treatment (radiation or surgery) can improve outcomes for men with a particularly aggressive form of prostate cancer (Gleason score 9-10). Participants will either receive standard treatment alone or standard treatment followed by several cycles of docetaxel. The study will track how long men live without their cancer returning or spreading, and whether the extra chemo improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
docetaxel (a chemotherapy drug), sometimes combined with carboplatin
What this could lead to
If effective, adding docetaxel after standard treatment could improve survival and delay cancer recurrence in men with high-risk prostate cancer.
What could go wrong
This is a non-randomized trial, so results may be less reliable. Chemotherapy can cause side effects, and it's uncertain if the benefits will outweigh risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 315 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed prostate cancer diagnosed by biopsy or surgery with a Gleason score of 9-10 (GG grade 5) or containing Gleason 5 components. 2. No evidence of distant metastasis confirmed by imaging. 3. Expected to receive standard radical treatment or postoperative radiotherapy. 4. Estimated survival time greater than 12 months. 5. Aged ≥ 18 years. 6. Karnofsky Performance Status (KPS) ≥ 80. 7. Adequate blood count: white blood cell ≥ 3.5 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100.0 × 10\^ Exclusion Criteria: 1. History of malignant tumors (except those cured for more than 5 years). 2. Previous abdominal radiation therapy. 3. Weight loss \> 10% within the past 6 months. 4. Pre-existing or concomitant bleeding disorders. 5. Active infections. 6. 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.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy Gleason score Prostate cancer Radiation therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hebei Yi Zhou Cancer Hospital

    RECRUITING

    Baoding, Hebei, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Peking University Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, China

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