Prostate Cancer Metastatic DiseasePhase 2NCT06992232
Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC
A Phase 2 study testing Intense androgen deprivation therapy, Radiation Therapy and radical prostatectomy in people with Prostate Cancer Metastatic Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Metastatic Disease
- What is being tested?
- Intense androgen deprivation therapy, Radiation Therapy and radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jul 2028
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.
- The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
- Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
- Patients must have adequate hematologic function, hepatic function and renal function.
- Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
- Fertile patients must be willing to use highly effective contraception during the study period.
Who cannot join
- Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
- The researchers assessed the primary lesion as unresectable.
- Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.
- Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
- Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months.
- Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.
- Within the past 5 years, having had other malignant tumors except for prostate cancer, with the exception of cured basal or squamous cell skin cancer.
- Suffering from mental illness, mental disability, or being incapable of providing informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hongqian Guo, PhD contact
China1 site, 1 recruiting
- Recruiting
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210008
Junlong Zhuang, MD, 8615950451917, zhuangjl-2008@163.com
About this study
Official title: Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial
This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.
- Conditions
- Prostate Cancer Metastatic Disease
- Being tested
- Intense androgen deprivation therapy, Radiation Therapy, radical prostatectomy
- Keywords
- metastatic prostate cancer, radiotherapy, prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense androgen deprivation therapyDrug
Also called ADT plus second-generation ARi
Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.
Radiation TherapyRadiation
Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. Radiation should be finished within 2 years' systemic therapy.
radical prostatectomyProcedure or surgery
Those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Surgery should be finished within 2 years' systemic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intense androgen deprivation therapy (IADT) | Active comparator | Patients received ADT plus ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years in the Intense androgen deprivation therapy (IADT) group. Receives: Drug: Intense androgen deprivation therapy |
| Radiotherapy or Surgery plus IADT | Experimental | For patients in the experimental group, local treatment either radiotherapy or surgery was arranged in addition to systemic ADT plus ARi. Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. While those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Receives: Drug: Intense androgen deprivation therapy; Radiation: Radiation Therapy; Procedure: radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival
Following 2 years of treatment, any anti-tumor treatment was terminated for those who met complete remission until two consecutively rised PSA>0.2ng/ml. Complete remission is interpreted as PSA level<0.1ng/ml and absence of radiographic as well as clinical progression following the 2-year treatment, both are indispensable. The primary outcome was event-free survival (EFS), defined as the time from disease complete remission to any required anti-tumor treatment.
Measured: 2 years
Secondary outcomes (3)
progression-free survival
Defined as from treatment initiation to PSA progression or radiographic/clinical progression. PSA progression is defined as PSA >1 ng/ml, with two consecutive PSA measurements at least one week apart showing a 50% or greater increase from baseline). Radiographic progression is defined as development of two or more new bone metastases or progression of soft tissue lesions according to RECIST 1.1 criteria. Clinical progression is defined as worsening clinical symptoms and signs as determined by the physician.
Measured: 4 years
Time to CRPC
Time to CRPC (castration-resistant prostate cancer (CRPC) is calculated from treatment initiation to the development of CRPC. CRPC is defined as serum testosterone at castration level (<50 ng/dl or 1.7 nmol/l), while meeting one of the following criteria: a. Biochemical progression: Three consecutive PSA rises, each measured at least one week apart, with at least two increases exceeding 50% above baseline, and at least one PSA value >2 ng/ml. b. Radiographic progression: Development of two or more new bone metastases, or progression of soft tissue lesions according to RECIST criteria.
Measured: 4 years
Adverse events
valuate all adverse events (AEs) and grade them according to NCI-CTCAE v5.0.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Hongqian Guo, PhD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992232
- Sponsor's protocol ID
- IUNU-PC-122
- Status last verified
- Apr 2025
- First submitted
- 19 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT06992232
- Acronym / sponsor ID
- IUNU-PC-122
- Conditions
- Prostate Cancer Metastatic Disease
- Keywords
- metastatic prostate cancer, radiotherapy, prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, Peking University First Hospital
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 May 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 multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intense androgen deprivation therapy (IADT) | Active comparator | Drug: Intense androgen deprivation therapyPatients received ADT plus ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years in the Intense androgen deprivation therapy (IADT) group. |
| Radiotherapy or Surgery plus IADT | Experimental | Drug: Intense androgen deprivation therapy, Radiation: Radiation Therapy, Procedure: radical prostatectomyFor patients in the experimental group, local treatment either radiotherapy or surgery was arranged in addition to systemic ADT plus ARi. Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. While those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. |
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)
- Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.
- The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
- Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
- Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
- Patients must have adequate hematologic function, hepatic function and renal function.
Key exclusion criteria (8 listed)
- Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
- The researchers assessed the primary lesion as unresectable.
- Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.
- Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
- Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months.
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 |
|---|---|---|
| Intense androgen deprivation therapyAlso: ADT plus second-generation ARiPatients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years. | Drug | Intense androgen deprivation therapy (IADT), Radiotherapy or Surgery plus IADT |
| Radiation TherapyThose allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. Radiation should be finished within 2 years' systemic therapy. | Radiation | Radiotherapy or Surgery plus IADT |
| radical prostatectomyThose allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Surgery should be finished within 2 years' systemic therapy. | Procedure or surgery | Radiotherapy or Surgery plus IADT |
Primary outcome
Event-free Survival
Time frame: 2 years
Following 2 years of treatment, any anti-tumor treatment was terminated for those who met complete remission until two consecutively rised PSA>0.2ng/ml. Complete remission is interpreted as PSA level<0.1ng/ml and absence of radiographic as well as clinical progression following the 2-year treatment, both are indispensable. The primary outcome was event-free survival (EFS), defined as the time from disease complete remission to any required anti-tumor treatment.
3 secondary outcomes
progression-free survival
Time frame: 4 years
Time to CRPC
Time frame: 4 years
Adverse events
Time frame: 4 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 28 May 2025.
- Individual participant dataSharing planned: Yes
Related trials for Prostate Cancer Metastatic Disease
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Hongqian Guo, PhD contact
Hongqian Guo, PhD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intense androgen deprivation therapy, Radiation Therapy and radical prostatectomy in people with Prostate Cancer Metastatic Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 7 inclusion and 8 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 28 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Junlong Zhuang, PhD (+86 15950451917, zhuangjl-2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free Survival (time frame: 2 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 28 May 2025.