Prostate CancerNCT07172685
Study on Triple Therapy Combined With HIFU for High-Tumor-Burden mHSPC
A study testing Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy in people with Prostate Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Jun 2027
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agree to participate in the study and sign the informed consent form.
- Age ≥18 years, male.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Bone scan, CT, or MRI showing ≥4 bone metastases (with ≥1 outside the pelvis or spine) or visceral metastases.
- Newly diagnosed or recurrent disease after local therapy, with sensitivity to androgen deprivation therapy (ADT).
- Patients who have received ADT (medical or surgical castration) with or without first-generation antiandrogens for ≤3 months, without evidence of soft tissue disease progression (per RECIST 1.1) or clinically significant PSA progression (≥50% increase from nadir with serum testosterone at castrate levels).
Show all 20Show fewer
- Planned treatment with docetaxel plus apalutamide and ADT, or apalutamide plus ADT.
- ECOG Performance Status (PS) score of 0-1.
- Adequate hematologic and organ function:
- Bone marrow function (without transfusion or growth factor support):
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/μL)
- Hemoglobin ≥90 g/L (9.0 g/dL)
- Platelet count ≥100 × 10⁹/L (100,000/μL)
- Liver function:
- Total bilirubin (TBIL) ≤1.5 × ULN
- AST, ALT, and alkaline phosphatase (ALP) ≤2.5 × ULN
- Renal function:
- Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
- Coagulation function (without anticoagulation therapy): INR ≤1.5
- Patients of reproductive potential must use effective contraception during the study and for 6 months after the last dose.
Who cannot join
- Lesions located at the prostate apex or in areas inaccessible for focal therapy.
- Beaded prostatic calculi or cysts >1 cm in diameter within the treatment or ultrasound pathway.
- Urethral stricture or presence of metal/other implants in the urethra.
- Prior rectal surgery.
- History of or existing rectal fistula.
- Rectal stenosis preventing transrectal ultrasound.
Show all 23Show fewer
- Rectal invasion.
- Active severe urinary tract infection.
- Severe cardiovascular or cerebrovascular disease affecting anesthesia/surgery.
- History of hypersensitivity or intolerance to any study drugs.
- Planned concurrent anticancer therapy during the study.
- Prior treatment with second-generation androgen receptor (AR) inhibitors (e.g., apalutamide, enzalutamide, darolutamide), CYP17 inhibitors (e.g., abiraterone acetate, ketoconazole), chemotherapy, immunotherapy, or adjuvant/neoadjuvant therapy.
- Use of herbal products with anti-prostate cancer or PSA-lowering effects (e.g., saw palmetto) within 4 weeks before study treatment.
- History of seizures, medications that lower seizure threshold, or conditions predisposing to seizures within 12 months (including TIA, stroke, or traumatic brain injury with hospitalization).
- Active cardiac disease within 6 months before treatment: severe/unstable angina, myocardial infarction, congestive heart failure (NYHA Class III/IV), or arrhythmia requiring medication.
- Conditions impairing drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Immunodeficiency (e.g., HIV-positive, congenital/acquired immunodeficiency) or organ transplant history.
- Known brain metastases.
- Other malignancies within 5 years (except cured basal cell carcinoma or cervical carcinoma in situ).
- Concurrent participation in another investigational drug/device trial.
- Poor compliance likely to hinder treatment/follow-up.
- Uncontrolled comorbidities (e.g., hypertension, diabetes, neuropsychiatric disorders) that may compromise safety or confound results, per investigator judgment.
- Any other condition deemed unsuitable for inclusion by the investigator.
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, 1 recruiting
- Recruiting
Qilu hospital
Jinan, Shandong, 276600
Shouzhen Chen, Dr., 18560089085, 201900412102@mail.sdu.edu.cn
About this study
Official title: Exploratory Study on the Efficacy and Safety of Triple Therapy (ADT + Darolutamide + Docetaxel Chemotherapy) Combined With Transrectal High-Intensity Focused Ultrasound Focal Therapy in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) With High Tumor Burden
This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC).
A total of 116 high-tumor-burden mHSPC patients will be enrolled and are scheduled to receive the following treatment:
Darolutamide + Docetaxel + ADT + Transrectal HIFU Focal Therapy for the Prostate.
Read the detailed description
Prostate cancer ranked as the second most commonly diagnosed cancer and the fifth leading cause of cancer death among men worldwide in 2020, with approximately 1.4 million new cases and 375,000 deaths. In China, both the incidence and mortality rates of prostate cancer have shown a significant upward trend.
For prostate cancer treatment, effective management of high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC) is crucial for delaying disease progression and improving long-term survival, representing one of the most critical clinical challenges. Although androgen deprivation therapy (ADT) combined with docetaxel or novel hormonal therapy has been established as standard treatment in both domestic and international guidelines, the clinical adoption of these novel ADT-based combination regimens remains limited due to the risk of adverse events (AEs) associated with chemotherapy and prolonged hormone exposure.
Recent advances in mHSPC treatment have brought new hope. The phase III PEACE-1 trial demonstrated that adding abiraterone to standard ADT plus docetaxel significantly reduced mortality risk (median overall survival not reached vs. 4.4 years; HR, 0.75; 95% CI, 0.59-0.96; P=0.021).
SonaCare Medical's Sonablate HIFU system is a global leader in high-intensity focused ultrasound technology, being the first prostate tissue ablation device to receive FDA 510(k) clearance. On July 8, 2020, the Sonablate device obtained approval from China's National Medical Products Administration (NMPA Approval No. 20203010342) for treating both prostate cancer and benign prostatic hyperplasia.
Therefore, this project proposes a single-arm clinical study. From 2022 to 2025, eligible high-tumor-burden mHSPC patients will be enrolled after providing informed consent and baseline data collection. Participants will receive either:
- Apalutamide + docetaxel + ADT, or
- Apalutamide + ADT combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy The primary endpoint is 3-year radiographic progression-free survival (rPFS) rate. Follow-up assessments will be conducted per protocol to evaluate efficacy and safety outcomes. This study aims to provide new therapeutic possibilities for high-tumor-burden mHSPC through combination therapy, potentially improving patient prognosis and reducing disease burden.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal 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.
Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal TherapyCombination product
Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy Group:
Darolutamide (600 mg, orally, twice daily) GnRHa (Goserelin 10.8 mg sustained-release implant, subcutaneous injection, every 3 months) Docetaxel (75 mg/m², intravenous infusion, every 3 weeks, for 6 cycles) Dexamethasone (8 mg, orally, 12/3/1 hour before docetaxel infusion)* Prednisone/Prednisolone (at the investigator's discretion)* Transrectal High-Intensity Focused Ultrasound (HIFU) for prostate focal therapy (ablation extent determined based on MRI and biopsy findings; number of treatments ≤ 2)
*Note: Dexamethasone and prednisone/prednisolone are adjunct medications and are not assigned as separate intervention arms; urinary catheter placement is a procedural detail and not listed as an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | The study plans to enroll 116 patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who will receive the following treatment regimen: Darolutamide , Docetaxel , ADT and transrectal high-intensity focused ultrasound (HIFU) focal therapy for the prostate. Patients will receive each drug according to the prescribing information, with dose adjustments based on adverse reactions (as per the prescribing guidelines). Receives: Combination Product: Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Evaluation
Time to PSA Progression
Measured: PSA Response Rate at Week 12
Secondary outcomes (3)
PFS
Measured: Time from randomization to tumor progression (any aspect) or death (any cause), or until a maximum of 2 years of drug exposure per subject, whichever occurs first.
PSA ≤0.2 ng/ml Response Rate
Measured: Months 3, 6, and 12
PSA50 and PSA90 Response Rates
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start30 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 Qilu Hospital of Shandong 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC).
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shouzhen Chen, Dr., Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172685
- Sponsor's protocol ID
- CSZ04
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Morris MJ, Rathkopf DE, Novotny W, Gibbons JA, Peterson AC, Khondker Z, Ouatas T, Scher HI, Fleming MT. Phase Ib Study of Enzalutamide in Combination with Docetaxel in Men with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2016 Aug 1;22(15):3774-81. doi: 10.1158/1078-0432.CCR-15-2638. Epub 2016 Feb 8.
PubMed 26858312Gan L, Chen S, Wang Y, Watahiki A, Bohrer L, Sun Z, Wang Y, Huang H. Inhibition of the androgen receptor as a novel mechanism of taxol chemotherapy in prostate cancer. Cancer Res. 2009 Nov 1;69(21):8386-94. doi: 10.1158/0008-5472.CAN-09-1504. Epub 2009 Oct 13.
PubMed 19826044Darshan MS, Loftus MS, Thadani-Mulero M, Levy BP, Escuin D, Zhou XK, Gjyrezi A, Chanel-Vos C, Shen R, Tagawa ST, Bander NH, Nanus DM, Giannakakou P. Taxane-induced blockade to nuclear accumulation of the androgen receptor predicts clinical responses in metastatic prostate cancer. Cancer Res. 2011 Sep 15;71(18):6019-29. doi: 10.1158/0008-5472.CAN-11-1417. Epub 2011 Jul 28.
PubMed 21799031Zhu Y, Liu C, Armstrong C, Lou W, Sandher A, Gao AC. Antiandrogens Inhibit ABCB1 Efflux and ATPase Activity and Reverse Docetaxel Resistance in Advanced Prostate Cancer. Clin Cancer Res. 2015 Sep 15;21(18):4133-42. doi: 10.1158/1078-0432.CCR-15-0269. Epub 2015 May 20.
PubMed 25995342Galletti G, Matov A, Beltran H, Fontugne J, Miguel Mosquera J, Cheung C, MacDonald TY, Sung M, O'Toole S, Kench JG, Suk Chae S, Kimovski D, Tagawa ST, Nanus DM, Rubin MA, Horvath LG, Giannakakou P, Rickman DS. ERG induces taxane resistance in castration-resistant prostate cancer. Nat Commun. 2014 Nov 25;5:5548. doi: 10.1038/ncomms6548.
PubMed 25420520Eigl BJ, Eggener SE, Baybik J, Ettinger S, Chi KN, Nelson C, Wang Z, Gleave ME. Timing is everything: preclinical evidence supporting simultaneous rather than sequential chemohormonal therapy for prostate cancer. Clin Cancer Res. 2005 Jul 1;11(13):4905-11. doi: 10.1158/1078-0432.CCR-04-2140.
PubMed 16000589Ueda Y, Matsubara N, Takizawa I, Nishiyama T, Tabata K, Satoh T, Kamiya N, Suzuki H, Kawahara T, Uemura H. A multicenter retrospective analysis of sequential treatment of abiraterone acetate followed by docetaxel in Japanese patients with metastatic castration-resistant prostate cancer. Jpn J Clin Oncol. 2015 Aug;45(8):774-9. doi: 10.1093/jjco/hyv070. Epub 2015 May 15.
PubMed 25981621Zhang T, Dhawan MS, Healy P, George DJ, Harrison MR, Oldan J, Chin B, Armstrong AJ. Exploring the Clinical Benefit of Docetaxel or Enzalutamide After Disease Progression During Abiraterone Acetate and Prednisone Treatment in Men With Metastatic Castration-Resistant Prostate Cancer. Clin Genitourin Cancer. 2015 Aug;13(4):392-399. doi: 10.1016/j.clgc.2015.01.004. Epub 2015 Jan 24.
PubMed 25708161Mezynski J, Pezaro C, Bianchini D, Zivi A, Sandhu S, Thompson E, Hunt J, Sheridan E, Baikady B, Sarvadikar A, Maier G, Reid AHM, Mulick Cassidy A, Olmos D, Attard G, de Bono J. Antitumour activity of docetaxel following treatment with the CYP17A1 inhibitor abiraterone: clinical evidence for cross-resistance? Ann Oncol. 2012 Nov;23(11):2943-2947. doi: 10.1093/annonc/mds119. Epub 2012 Jul 5.
PubMed 22771826de Bono JS, Chowdhury S, Feyerabend S, Elliott T, Grande E, Melhem-Bertrandt A, Baron B, Hirmand M, Werbrouck P, Fizazi K. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for >/=24 weeks in Europe. Eur Urol. 2018 Jul;74(1):37-45. doi: 10.1016/j.eururo.2017.07.035. Epub 2017 Aug 23.
PubMed 28844372Matsubara N, Yamada Y, Tabata KI, Satoh T, Kamiya N, Suzuki H, Kawahara T, Uemura H, Yano A, Kawakami S, Otsuka M, Fukasawa S. Abiraterone Followed by Enzalutamide Versus Enzalutamide Followed by Abiraterone in Chemotherapy-naive Patients With Metastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2018 Apr;16(2):142-148. doi: 10.1016/j.clgc.2017.09.008. Epub 2017 Sep 23.
PubMed 29042308Khalaf DJ, Annala M, Taavitsainen S, Finch DL, Oja C, Vergidis J, Zulfiqar M, Sunderland K, Azad AA, Kollmannsberger CK, Eigl BJ, Noonan K, Wadhwa D, Attwell A, Keith B, Ellard SL, Le L, Gleave ME, Wyatt AW, Chi KN. Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2, crossover trial. Lancet Oncol. 2019 Dec;20(12):1730-1739. doi: 10.1016/S1470-2045(19)30688-6. Epub 2019 Nov 11.
PubMed 31727538McGuire S. World Cancer Report 2014. Geneva, Switzerland: World Health Organization, International Agency for Research on Cancer, WHO Press, 2015. Adv Nutr. 2016 Mar 15;7(2):418-9. doi: 10.3945/an.116.012211. Print 2016 Mar. No abstract available.
PubMed 26980827
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy and Safety of Triple Therapy (ADT + Darolutamide + Docetaxel Chemotherapy) Combined With Transrectal High-Intensity Focused Ultrasound Focal Therapy in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) With High Tumor Burden
- ClinicalTrials.gov ID
- NCT07172685
- Acronym / sponsor ID
- CSZ04
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Sep 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 is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC).
A total of 116 high-tumor-burden mHSPC patients will be enrolled and are scheduled to receive the following treatment:
Darolutamide + Docetaxel + ADT + Transrectal HIFU Focal Therapy for the Prostate.
Detailed description
Prostate cancer ranked as the second most commonly diagnosed cancer and the fifth leading cause of cancer death among men worldwide in 2020, with approximately 1.4 million new cases and 375,000 deaths. In China, both the incidence and mortality rates of prostate cancer have shown a significant upward trend.
For prostate cancer treatment, effective management of high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC) is crucial for delaying disease progression and improving long-term survival, representing one of the most critical clinical challenges. Although androgen deprivation therapy (ADT) combined with docetaxel or novel hormonal therapy has been established as standard treatment in both domestic and international guidelines, the clinical adoption of these novel ADT-based combination regimens remains limited due to the risk of adverse events (AEs) associated with chemotherapy and prolonged hormone exposure.
Recent advances in mHSPC treatment have brought new hope. The phase III PEACE-1 trial demonstrated that adding abiraterone to standard ADT plus docetaxel significantly reduced mortality risk (median overall survival not reached vs. 4.4 years; HR, 0.75; 95% CI, 0.59-0.96; P=0.021).
SonaCare Medical's Sonablate HIFU system is a global leader in high-intensity focused ultrasound technology, being the first prostate tissue ablation device to receive FDA 510(k) clearance. On July 8, 2020, the Sonablate device obtained approval from China's National Medical Products Administration (NMPA Approval No. 20203010342) for treating both prostate cancer and benign prostatic hyperplasia.
Therefore, this project proposes a single-arm clinical study. From 2022 to 2025, eligible high-tumor-burden mHSPC patients will be enrolled after providing informed consent and baseline data collection. Participants will receive either:
- Apalutamide + docetaxel + ADT, or
- Apalutamide + ADT combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy The primary endpoint is 3-year radiographic progression-free survival (rPFS) rate. Follow-up assessments will be conducted per protocol to evaluate efficacy and safety outcomes. This study aims to provide new therapeutic possibilities for high-tumor-burden mHSPC through combination therapy, potentially improving patient prognosis and reducing disease burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC).
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Combination Product: Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal TherapyThe study plans to enroll 116 patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who will receive the following treatment regimen: Darolutamide , Docetaxel , ADT and transrectal high-intensity focused ultrasound (HIFU) focal therapy for the prostate. Patients will receive each drug according to the prescribing information, with dose adjustments based on adverse reactions (as per the prescribing guidelines). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients who agree to participate in the study and sign the informed consent form.
- Age ≥18 years, male.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Bone scan, CT, or MRI showing ≥4 bone metastases (with ≥1 outside the pelvis or spine) or visceral metastases.
- Newly diagnosed or recurrent disease after local therapy, with sensitivity to androgen deprivation therapy (ADT).
Key exclusion criteria (23 listed)
- Lesions located at the prostate apex or in areas inaccessible for focal therapy.
- Beaded prostatic calculi or cysts >1 cm in diameter within the treatment or ultrasound pathway.
- Urethral stricture or presence of metal/other implants in the urethra.
- Prior rectal surgery.
- History of or existing rectal fistula.
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 |
|---|---|---|
| Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal TherapyDarolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy Group: Darolutamide (600 mg, orally, twice daily) GnRHa (Goserelin 10.8 mg sustained-release implant, subcutaneous injection, every 3 months) Docetaxel (75 mg/m², intravenous infusion, every 3 weeks, for 6 cycles) Dexamethasone (8 mg, orally, 12/3/1 hour before docetaxel infusion)* Prednisone/Prednisolone (at the investigator's discretion)* Transrectal High-Intensity Focused Ultrasound (HIFU) for prostate focal therapy (ablation extent determined based on MRI and biopsy findings; number of treatments ≤ 2) *Note: Dexamethasone and prednisone/prednisolone are adjunct medications and are not assigned as separate intervention arms; urinary catheter placement is a procedural detail and not listed as an intervention. | Combination product | Experimental Arm |
Primary outcome
PSA Evaluation
Time frame: PSA Response Rate at Week 12
Time to PSA Progression
3 secondary outcomes
PFS
Time frame: Time from randomization to tumor progression (any aspect) or death (any cause), or until a maximum of 2 years of drug exposure per subject, whichever occurs first.
PSA ≤0.2 ng/ml Response Rate
Time frame: Months 3, 6, and 12
PSA50 and PSA90 Response Rates
Time frame: Month 6
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 15 Sep 2025.
- Results publication: PubMed 26858312Morris MJ, Rathkopf DE, Novotny W, Gibbons JA, Peterson AC, Khondker Z, Ouatas T, Scher HI, Fleming MT. Phase Ib Study of Enzalutamide in Combination with Docetaxel in Men with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2016 Aug 1;22(15):3774-81. doi: 10.1158/1078-0432.CCR-15-2638. Epub 2016 Feb 8.
- Results publication: PubMed 19826044Gan L, Chen S, Wang Y, Watahiki A, Bohrer L, Sun Z, Wang Y, Huang H. Inhibition of the androgen receptor as a novel mechanism of taxol chemotherapy in prostate cancer. Cancer Res. 2009 Nov 1;69(21):8386-94. doi: 10.1158/0008-5472.CAN-09-1504. Epub 2009 Oct 13.
- Results publication: PubMed 21799031Darshan MS, Loftus MS, Thadani-Mulero M, Levy BP, Escuin D, Zhou XK, Gjyrezi A, Chanel-Vos C, Shen R, Tagawa ST, Bander NH, Nanus DM, Giannakakou P. Taxane-induced blockade to nuclear accumulation of the androgen receptor predicts clinical responses in metastatic prostate cancer. Cancer Res. 2011 Sep 15;71(18):6019-29. doi: 10.1158/0008-5472.CAN-11-1417. Epub 2011 Jul 28.
- Results publication: PubMed 25995342Zhu Y, Liu C, Armstrong C, Lou W, Sandher A, Gao AC. Antiandrogens Inhibit ABCB1 Efflux and ATPase Activity and Reverse Docetaxel Resistance in Advanced Prostate Cancer. Clin Cancer Res. 2015 Sep 15;21(18):4133-42. doi: 10.1158/1078-0432.CCR-15-0269. Epub 2015 May 20.
- Results publication: PubMed 25420520Galletti G, Matov A, Beltran H, Fontugne J, Miguel Mosquera J, Cheung C, MacDonald TY, Sung M, O'Toole S, Kench JG, Suk Chae S, Kimovski D, Tagawa ST, Nanus DM, Rubin MA, Horvath LG, Giannakakou P, Rickman DS. ERG induces taxane resistance in castration-resistant prostate cancer. Nat Commun. 2014 Nov 25;5:5548. doi: 10.1038/ncomms6548.
- Results publication: PubMed 16000589Eigl BJ, Eggener SE, Baybik J, Ettinger S, Chi KN, Nelson C, Wang Z, Gleave ME. Timing is everything: preclinical evidence supporting simultaneous rather than sequential chemohormonal therapy for prostate cancer. Clin Cancer Res. 2005 Jul 1;11(13):4905-11. doi: 10.1158/1078-0432.CCR-04-2140.
- Results publication: PubMed 25981621Ueda Y, Matsubara N, Takizawa I, Nishiyama T, Tabata K, Satoh T, Kamiya N, Suzuki H, Kawahara T, Uemura H. A multicenter retrospective analysis of sequential treatment of abiraterone acetate followed by docetaxel in Japanese patients with metastatic castration-resistant prostate cancer. Jpn J Clin Oncol. 2015 Aug;45(8):774-9. doi: 10.1093/jjco/hyv070. Epub 2015 May 15.
- Results publication: PubMed 25708161Zhang T, Dhawan MS, Healy P, George DJ, Harrison MR, Oldan J, Chin B, Armstrong AJ. Exploring the Clinical Benefit of Docetaxel or Enzalutamide After Disease Progression During Abiraterone Acetate and Prednisone Treatment in Men With Metastatic Castration-Resistant Prostate Cancer. Clin Genitourin Cancer. 2015 Aug;13(4):392-399. doi: 10.1016/j.clgc.2015.01.004. Epub 2015 Jan 24.
- Results publication: PubMed 22771826Mezynski J, Pezaro C, Bianchini D, Zivi A, Sandhu S, Thompson E, Hunt J, Sheridan E, Baikady B, Sarvadikar A, Maier G, Reid AHM, Mulick Cassidy A, Olmos D, Attard G, de Bono J. Antitumour activity of docetaxel following treatment with the CYP17A1 inhibitor abiraterone: clinical evidence for cross-resistance? Ann Oncol. 2012 Nov;23(11):2943-2947. doi: 10.1093/annonc/mds119. Epub 2012 Jul 5.
- Results publication: PubMed 28844372de Bono JS, Chowdhury S, Feyerabend S, Elliott T, Grande E, Melhem-Bertrandt A, Baron B, Hirmand M, Werbrouck P, Fizazi K. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for >/=24 weeks in Europe. Eur Urol. 2018 Jul;74(1):37-45. doi: 10.1016/j.eururo.2017.07.035. Epub 2017 Aug 23.
- Results publication: PubMed 29042308Matsubara N, Yamada Y, Tabata KI, Satoh T, Kamiya N, Suzuki H, Kawahara T, Uemura H, Yano A, Kawakami S, Otsuka M, Fukasawa S. Abiraterone Followed by Enzalutamide Versus Enzalutamide Followed by Abiraterone in Chemotherapy-naive Patients With Metastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2018 Apr;16(2):142-148. doi: 10.1016/j.clgc.2017.09.008. Epub 2017 Sep 23.
- Results publication: PubMed 31727538Khalaf DJ, Annala M, Taavitsainen S, Finch DL, Oja C, Vergidis J, Zulfiqar M, Sunderland K, Azad AA, Kollmannsberger CK, Eigl BJ, Noonan K, Wadhwa D, Attwell A, Keith B, Ellard SL, Le L, Gleave ME, Wyatt AW, Chi KN. Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2, crossover trial. Lancet Oncol. 2019 Dec;20(12):1730-1739. doi: 10.1016/S1470-2045(19)30688-6. Epub 2019 Nov 11.
- 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.
Shouzhen Chen, Dr. study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Darolutamide , Docetaxel , ADT and Transrectal HIFU Focal Therapy in people with Prostate Cancer, run by Qilu Hospital of Shandong 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 20 inclusion and 23 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 15 Sep 2025. 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 Shouzhen Chen, Dr. (18560089085, chensz@mail.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Evaluation (time frame: PSA Response Rate at Week 12). 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 NCT07172685, which also lists 13 linked publications.
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 15 Sep 2025.