Oligometastatic Prostate CarcinomaNCT05707468
Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer
A study testing ADT combined with abiraterone and neoadjuvant hormone and RT in people with Oligometastatic Prostate Carcinoma, run by Changhai Hospital at 6 sites in China.
Trial summary
The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Oligometastatic Prostate Carcinoma
- What is being tested?
- ADT combined with abiraterone and neoadjuvant hormone and RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesChina
- Study dates
- 1 May 2024to 1 Mar 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate without small cell features
- Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT
- <4 bone oligometastases, lymph node metastasis below the renal artery level
- Expected survival time >5 years
- World Health Organization (WHO) performance status 0-1
- Be willing to give written informed consent.
Who cannot join
- Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.
- Patients who have previously undergone transurethral resection or enucleation of the prostate.
- Patients who have undergone other abdominal surgery within the last 3 months
- Patients who have visceral metastases
- Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration
- Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis
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- Severe or active comorbidities likely to impact the advisability of radiotherapy
- Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patient
- Patients who have participated in other clinical trials within the last 3 months
- Patients who refuse to undergo RALP
- Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Di Gu, PhD
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Zejun Yan, PhD
The Second Affiliated Hospital of Naval Medical University
Shanghai, 200003
Shancheng Ren, PhD, 021-81885721, renshancheng@gmail.com
The First Affiliated Hospital of Naval Medical University
Shanghai, 200433
Huojun Zhang, PhD, 021-31162222, huojunzh@163.com
First Affiliated Hospital and Medical College of Soochow University
Suzhou, Jiangsu
Xiang Ding, PhD
Jiangnan University Medical Center
Wuxi, Jiangsu, 210009
Ninghan Feng, PhD
About this study
Official title: Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial
The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.
Read the detailed description
The present study will be conducted as a prospective, open-label, two arms clinical trial. Patients with ≤ 3 de novo oligometastatic PCa, diagnosed on Ga-68 prostate-specific membrane antigen (PSMA) PET/CT, will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT). The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. The primary endpoints of the study are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS). The secondary endpoints include quality of life (QoL), time to CRPC, positive surgical margin (pSM), overall survival (OS), postoperative continence, and toxicities parameters.
- Conditions
- Oligometastatic Prostate Carcinoma
- Being tested
- ADT combined with abiraterone, neoadjuvant hormone and RT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADT combined with abirateroneDrug
The patients will receive long-term ADT combined with abiraterone.
neoadjuvant hormone and RTRadiation
The patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.
| Study group | Role | What they receive |
|---|---|---|
| A (hormone) | Active comparator | The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. Receives: Drug: ADT combined with abiraterone |
| B (neoadjuvant hormone and RT) | Experimental | The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. Receives: Radiation: neoadjuvant hormone and RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival (PFS)
To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).
Measured: Assessment progression-free survival (PFS) at 3 years
Secondary outcomes (3)
quality of life (QoL)
quality of life (QoL)
Measured: through study completion, an average of 3 years
time to castration-resistant prostate cancer (CRPC)
To assess the time to castration-resistant prostate cancer (CRPC)
Measured: through study completion, an average of 3 years
5-year overall survival (OS)
To assess the overall survival (OS)
Measured: Assessment overall survival (OS) at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oligometastatic Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707468
- Sponsor's protocol ID
- Changhai Hospital PCa
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.
Publications
Fan Z, Li D, Yan S, Zhao X, Yin L, Xu W, Wang Y, Zhang H, Chang Y, Ren S. NEoAdjuvant radiohormonal therapy versus standard of care for oligometastatic prostate cancer (NEAR-TOP): study protocol of a multicenter, open-label, randomised controlled trial. BMC Cancer. 2025 Apr 24;25(1):768. doi: 10.1186/s12885-024-13201-w.
PubMed 40275195
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05707468
- Acronym / sponsor ID
- Changhai Hospital PCa
- Conditions
- Oligometastatic Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 1 Feb 2023 (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.
The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.
Detailed description
The present study will be conducted as a prospective, open-label, two arms clinical trial. Patients with ≤ 3 de novo oligometastatic PCa, diagnosed on Ga-68 prostate-specific membrane antigen (PSMA) PET/CT, will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT). The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. The primary endpoints of the study are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS). The secondary endpoints include quality of life (QoL), time to CRPC, positive surgical margin (pSM), overall survival (OS), postoperative continence, and toxicities parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT).
| Arm | Type | Receives |
|---|---|---|
| A (hormone) | Active comparator | Drug: ADT combined with abirateroneThe patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. |
| B (neoadjuvant hormone and RT) | Experimental | Radiation: neoadjuvant hormone and RTThe patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed adenocarcinoma of the prostate without small cell features
- Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT
- <4 bone oligometastases, lymph node metastasis below the renal artery level
- Expected survival time >5 years
- World Health Organization (WHO) performance status 0-1
Key exclusion criteria (11 listed)
- Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.
- Patients who have previously undergone transurethral resection or enucleation of the prostate.
- Patients who have undergone other abdominal surgery within the last 3 months
- Patients who have visceral metastases
- Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration
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 |
|---|---|---|
| ADT combined with abirateroneThe patients will receive long-term ADT combined with abiraterone. | Drug | A (hormone) |
| neoadjuvant hormone and RTThe patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. | Radiation | B (neoadjuvant hormone and RT) |
Primary outcome
3-year progression-free survival (PFS)
Time frame: Assessment progression-free survival (PFS) at 3 years
To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).
3 secondary outcomes
quality of life (QoL)
Time frame: through study completion, an average of 3 years
time to castration-resistant prostate cancer (CRPC)
Time frame: through study completion, an average of 3 years
5-year overall survival (OS)
Time frame: Assessment overall survival (OS) at 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 Feb 2024.
- Derived from this study: PubMed 40275195Fan Z, Li D, Yan S, Zhao X, Yin L, Xu W, Wang Y, Zhang H, Chang Y, Ren S. NEoAdjuvant radiohormonal therapy versus standard of care for oligometastatic prostate cancer (NEAR-TOP): study protocol of a multicenter, open-label, randomised controlled trial. BMC Cancer. 2025 Apr 24;25(1):768. doi: 10.1186/s12885-024-13201-w.
- Individual participant dataSharing planned: Yes. Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADT combined with abiraterone and neoadjuvant hormone and RT in people with Oligometastatic Prostate Carcinoma, run by Changhai Hospital at 6 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 6 inclusion and 11 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Contact Huojun Zhang, PhD (021-31162222, huojunzh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression-free survival (PFS) (time frame: Assessment progression-free survival (PFS) at 3 years). 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 NCT05707468, which also lists 1 linked publication.
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 Feb 2024.