Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Local treatment: For bone lesions, radiotherapy or orthopedic surgery may be selected. For lymph node lesions, radiotherapy, high-energy focused ultrasound (HIFU) or other available options maybe selected. The specific treatment plan will be determined by the researcher and based on the patient's clinical condition.

Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide).: The intervention contains gonadotropin releasing hormone analog (GnRHa) and novel hormone therapy. For GnRHa, there are 3 options available. 1. "Leuprorelin"/"Prostap" or "Staladex". 2. "Goserelin"/"Zoladex". 3. "Triptorelin" /"LiverTox". For novel hormone therapy, there are also 3 options available. 1. "Abiraterone"/ "ZYTIGA®". 2. "Apalutamide"/"ERLEADA®". 3. "Rezvilutamide"/"ARIANE®". The specific treatment plan will be designed according to patients' clinical conditions based on EAU guidelines.

Study summary

At present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mHSPC). Major guidelines and consensus suggest that novel hormone therapy (NHT) should be used as the basic treatment for mHSPC, and metastasis directed therapy can be combined depending on the clinical situation. However, it is still unclear how to develop more specific and individualized treatment plans for mHSPC patients. On the other hand, prostate-specific membrane antigen (PSMA) which is highly specifically expressed in prostate epithelial cells has been widely used as a PET/CT target for the diagnosis and staging of prostate cancer. However, there is still a lack of clinical evidence on how to use it to guide the treatment of prostate cancer. Therefore, this study intends to include patients diagnosed with mHSPC by PSMA PET/CT. The patients received no prior treatment for prostate cancer or ADT plus NHT therapy only. After 8 months of ADT plus NHT, PSMA PET/CT will be re-evaluated and patients with remaining active lesions on PSMA PET/CT will be included for randomization. The aim of this study is to explore the effect of NHT combined with local treatment on delaying disease progression and prolonging survival in patients with active lesions on PSMA PET/CT after NHT, providing new insights into the treatment of mHSCP patients.

Eligibility

Primary outcome measure(s)

• Progression free survival, PFS — From enrollment to the end of treatment at 12 weeks
  Progression includes biochemical progression, clinical progression, and imaging progression. The definition of biochemical progression is a PSA increase of more than 25% and an absolute increase of 2ng/ml compared above baseline or nadir. The definition of clinical progression is the emergence of any new clinical symptoms related to the primary and metastatic lesions of prostate cancer. The definition of imaging progression is the appearance of any new metastatic lesion in CT/MR/PET/CT scan. When one of the above criteria is met, it can be considered as disease progression.

Trial sites (1)

More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China

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