Clinical trial NCT06972511: Maximal Tumor Eradication for Oligometastatic Prostate Cancer
Official title: Apatamide Combined With Maximal Tumor Eradication for Oligometastatic Prostate Cancer, A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Oligometastatic Prostate Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Time to hormone-resistant prostate cancer （TTCRPC）
timeFrame: 5 years
Secondary outcomes:
measure: overall survival rate
timeFrame: 5 years
measure: time to clinical imaging progression in both groups
timeFrame: 5 years
measure: pathological complete response rate
timeFrame: 5 years
measure: minimum PSA after 6 months of treatment in the two groups
timeFrame: 5 years
measure: annual EORTC QLQC-30 score after treatment
timeFrame: 5 years
measure: survival rate of disease-free progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi hospital, school of Medicine, Shanghai Jiao Tong University
Study officials:
References: