Prostate CancerNCT07311915
Propranolol Combined With Novel Endocrine Therapy and Androgen Deprivation Therapy (ADT) for Neoadjuvant Treatment in High-Risk Prostate Cancer Patients: A Multicenter, Single-Arm Clinical Study
A study testing Propranolol combined with novel endocrine therapy and androgen deprivation therapy in people with Prostate Cancer, run by Zhongda Hospital at 1 site in China.
Trial summary
Propranolol, a non-selective adrenergic beta-receptor blocker, is conventionally used to treat arrhythmias. However, recent studies have demonstrated its therapeutic efficacy in breast cancer, prostate cancer, neonatal hemangioma, and neonatal facial rhabdomyoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Propranolol combined with novel endocrine therapy and androgen deprivation therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 30 Sep 2028
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 85 years;
- High-risk prostate cancer patients. High-risk prostate cancer is defined as: organ-confined high-risk/very high-risk prostate cancer and locally advanced prostate cancer. High-risk/very high-risk is specifically defined as PSA > 20 ng/mL, biopsy Gleason score ≥ 8, or clinical T stage cT2c or higher, meeting at least one of these three criteria, and without distant metastasis. Local progression typically refers to pelvic lymph node metastasis only; ③ Patients diagnosed with mild to moderate primary hypertension according to the Chinese Hypertension Prevention and Treatment Guidelines (2024 Revised Edition). Hypertension is defined as:
- Office blood pressure ≥140/90 mmHg without antihypertensive medication; or home blood pressure ≥135/85 mmHg; or 24-hour ambulatory blood pressure ≥130/80 mmHg, with daytime blood pressure ≥135/85 mmHg and nighttime blood pressure ≥120/70 mmHg. Specifically: - Systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg constitutes mild hypertension; - Systolic blood pressure 160-179 mmHg and/or diastolic blood pressure 100-109 mmHg constitutes moderate hypertension.
- For patient screening, office blood pressure must meet any one of the following criteria:
- Primary hypertension patients who have not used any antihypertensive medication for at least 4 weeks prior to screening, with an average seated office blood pressure (mean of 3 measurements) of 150 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;
- Patients with primary hypertension who have been on stable doses of 1-2 antihypertensive agents (including monotherapy, dual therapy, or fixed-dose combinations) for at least 4 weeks prior to screening, and who are deemed clinically suitable for switching to propranolol or nifedipine, with an average seated office blood pressure of 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg; ⑤ ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
- ⑥ All patients voluntarily sign informed consent and are able to adhere to treatment and follow-up;
- ⑦ Prostate cancer biopsy specimens and surgically resected tissue are available for subsequent analysis, with sufficient tumor cell content in the pathological specimens;
Who cannot join
- Any prior or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.;
- Individuals contraindicated for propranolol. Specifically including: 1) Patients with asthma and allergic rhinitis; 2) Patients with cardiovascular disease: sinus bradycardia, severe atrioventricular block, cardiogenic shock; 3) Patients with cardiac insufficiency; 4) Patients with hepatic impairment; 5) Patients with hypothyroidism; ③ Patients who have recently (within 3 months) taken beta-blocker medications (e.g., carvedilol, metoprolol);
- Patients with known allergies to any medication used; ⑤ Patients on long-term antiarrhythmic drugs (e.g., amiodarone, sotalol, digoxin, verapamil, flecainide); ⑥ Patients deemed unsuitable for this clinical study by the investigator's judgment;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital
Nanjing
Yifan Liu, 86-13805102109, yifanliuseu@126.com
About this study
Propranolol, a non-selective adrenergic beta-receptor blocker, is conventionally used to treat arrhythmias. However, recent studies have demonstrated its therapeutic efficacy in breast cancer, prostate cancer, neonatal hemangioma, and neonatal facial rhabdomyoma. Given the significant potential of neoadjuvant therapy in prostate cancer, we designed a multicenter, single-arm clinical study. This trial evaluates neoadjuvant propranolol combined with novel endocrine therapy and androgen deprivation therapy (ADT) in high-risk prostate cancer patients prior to radical prostatectomy, aiming to achieve superior curative outcomes.
- Conditions
- Prostate Cancer
- Being tested
- Propranolol combined with novel endocrine therapy and androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol combined with novel endocrine therapy and androgen deprivation therapyDrug
Patients in the group received daily oral propranolol therapy: the initial oral dose was 10 mg three times daily, with adjustments made by the clinician based on the patient's blood pressure status; concurrently administered were continuous novel endocrine therapy and androgen deprivation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol combined with novel endocrine therapy and androgen deprivation therapy | Experimental | Not described Receives: Drug: Propranolol combined with novel endocrine therapy and androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response
pCR (pathological complete response) is defined as the absence of morphologically recognizable cancer in the prostate resection specimen.
Measured: From enrollment to the end of treatment at 12 weeks
Minimal Residual Disease
MRD (Minimal Residual Disease) is defined as residual tumors with a maximum cross-sectional dimension ≤5 mm and a residual cancer burden (RCB) ≤0.25 cm³ (tumor volume ≤0.5 cm³ × tumor cell content ≤50%). Tumor volume is calculated via three-dimensional volume estimation based on the maximum cross-sectional dimension and number of cross-sections involved, with correction for tumor cell architecture.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, baotai Liang, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311915
- Sponsor's protocol ID
- 2025ZDSYLL131-P01
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol Combined With Novel Endocrine Therapy and Androgen Deprivation Therapy (ADT) for Neoadjuvant Treatment in High-Risk Prostate Cancer Patients: A Multicenter, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07311915
- Acronym / sponsor ID
- 2025ZDSYLL131-P01
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 31 Dec 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.
Propranolol, a non-selective adrenergic beta-receptor blocker, is conventionally used to treat arrhythmias. However, recent studies have demonstrated its therapeutic efficacy in breast cancer, prostate cancer, neonatal hemangioma, and neonatal facial rhabdomyoma. Given the significant potential of neoadjuvant therapy in prostate cancer, we designed a multicenter, single-arm clinical study. This trial evaluates neoadjuvant propranolol combined with novel endocrine therapy and androgen deprivation therapy (ADT) in high-risk prostate cancer patients prior to radical prostatectomy, aiming to achieve superior curative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propranolol combined with novel endocrine therapy and androgen deprivation therapy | Experimental | Drug: Propranolol combined with novel endocrine therapy and androgen deprivation therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and ≤ 85 years;
- ⑥ All patients voluntarily sign informed consent and are able to adhere to treatment and follow-up;
- ⑦ Prostate cancer biopsy specimens and surgically resected tissue are available for subsequent analysis, with sufficient tumor cell content in the pathological specimens;
Key exclusion criteria (3 listed)
- Any prior or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.;
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 |
|---|---|---|
| Propranolol combined with novel endocrine therapy and androgen deprivation therapyPatients in the group received daily oral propranolol therapy: the initial oral dose was 10 mg three times daily, with adjustments made by the clinician based on the patient's blood pressure status; concurrently administered were continuous novel endocrine therapy and androgen deprivation therapy. | Drug | Propranolol combined with novel endocrine therapy and androgen deprivation therapy |
Primary outcome
pathological complete response
Time frame: From enrollment to the end of treatment at 12 weeks
pCR (pathological complete response) is defined as the absence of morphologically recognizable cancer in the prostate resection specimen.
Minimal Residual Disease
Time frame: From enrollment to the end of treatment at 12 weeks
MRD (Minimal Residual Disease) is defined as residual tumors with a maximum cross-sectional dimension ≤5 mm and a residual cancer burden (RCB) ≤0.25 cm³ (tumor volume ≤0.5 cm³ × tumor cell content ≤50%). Tumor volume is calculated via three-dimensional volume estimation based on the maximum cross-sectional dimension and number of cross-sections involved, with correction for tumor cell architecture.
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 6 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol combined with novel endocrine therapy and androgen deprivation therapy in people with Prostate Cancer, run by Zhongda Hospital 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 8 inclusion and 3 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 6 Jan 2026. 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.
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 Yifan Liu (86-13805102109, yifanliuseu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (time frame: From enrollment to the end of treatment at 12 weeks). 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 6 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.