NCT06972511 Maximal Tumor Eradication for Oligometastatic Prostate Cancer
| NCT ID | NCT06972511 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | RenJi Hospital |
| Condition | Oligometastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-08-20 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2023-08-20 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In China, the incidence of prostate cancer is increasing in recent years, and it has ranked 5th among common male tumors and 1st in urinary tumors. Unlike developed countries in Europe and the United States, in China, because prostate-specific antigen (PSA) screening has not been widely popularized, and early prostate cancer is mostly asymptomatic, about 13%-26% of prostate cancer patients have progressed to metastatic hormone-sensitive prostate cancer (mHSPC) at the time of initial diagnosis. Compared with localized prostate cancer, the 5-year survival rate of mHSPC is only 29.3%, which is prone to symptoms such as bone pain, pathological fracture, hematuria, and dysuria and seriously decrease the survival and quality of life. As a result, it is of great significance to carry out more refined management of mHSPC, explore more scientific treatment options, and delay the time to CRPC, which is of great significance for improving the prognosis and quality of life of patients and reducing medical burden. However, there is still no standard treatment strategy for OMPC patients which need more clinical exploration. Treatment of prostate primary in oligometastatic prostate cancer (OMPC) may improve survival and do not significantly increase complications. Radiotherapy showed excellent therapeutic effects on metastatic lesions, prolonged survival and without increasing significant adverse effects. In 2019, The New England Journal of Medicine reported a TITAN study that combining apatamide with ADT for metastatic hormone-sensitive prostate cancer, which significantly reduced the risk of death (82.4% VS 72.5%, P=0.005), and improved progression-free survival (68.2% VS 47.5, P \<0.001) without increasing adverse effects of treatment. In 2020, Johns Hopkins University published a phase I clinical study of radical treatment of 12 cases of OMPC. Patients were treated with neoadjuvant docetaxel chemotherapy or abiraterone, combined with radical prostatectomy for primary lesions, and stereotactic radiation for bone metastases to achieve the purpose of complete tumor eradication. Preliminary results showed that no additional complications were found except neutropenic fever in two cases. At the same time, the proportion of PSA maintained undetectable in 1,2,3 years was 12 / 12 (100%), 10 / 12 (83%) and 8 / 12 (67%), respectively, showing good treatment results. Since 2014, the applicant has rich research experience in the treatment of oligometastatic prostate cancer and our results showed that systemic therapy combined with local tumor reduction therapy can confer a survival benefit for OMPC patients without a significant increase in complications. This clinical trial aimed to analyze the clinical efficacy and safety of maximal tumor eradication strategy for oligometastatic prostate cancer.
Eligibility Criteria
Inclusion Criteria: * Age less than 75 years * EORTC QLQC-30 score 2 * Life expectancy of 10 years * Patients with oligometastatic prostate cancer on clinicopathological assessment * Patients are suitable for radiotherapy and prostatectomy surgery * Patients agree to participate in the study and sign the informed consent form before enrollment Exclusion Criteria: * Tumor related fracture * Cannot accept radiotherapy * Visceral metastasis * Serious infection * Thromboembolism history * Not effectively controlled cardiovascular complications
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06972511 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 75 Years, studying Oligometastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06972511 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06972511 currently recruiting?
Yes, NCT06972511 is actively recruiting participants. Contact the research team at jiahua.pan@outlook.com for enrollment information.
Where is the NCT06972511 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06972511 clinical trial?
NCT06972511 is sponsored by RenJi Hospital. The trial plans to enroll 120 participants.
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