This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.

Inclusion Criteria:

• Signed the informed consent form.
• Male, aged ≥ 18 years.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Metastatic prostate cancer.
• Organ function meet protocol requirements.
• Recovered from all reversible AEs related to previous anticancer treatments.

Exclusion Criteria:

• Previous treatment with the following drugs:

  1. AR PROTAC class drugs.
  2. Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment.
  3. Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment.
  4. Drugs that may cause drug-drug interactions (DDI) with the study treatment.
  5. Drugs known to prolong the QT interval or potentially cause torsades de pointes ventricular tachycardia

• Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression.

• Radiation therapy involving more than 25% of bone marrow within 4 weeks prior to the first administration of the investigational medicinal product; local radiation therapy within 2 weeks prior to the first administration of the investigational medicinal product.

• Treatment with other investigational drugs or major surgery within 4 weeks.

• Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.

• With severe cardiovascular or cerebrovascular diseases or related history.

• Active, uncontrolled infections.

• History of other significant malignancies within 5 years.

• Moderate to severe pulmonary disease significantly affecting lung function.

• According to the investigator's judgment, there are comorbidities that seriously endanger subject safety or affect the subject's ability to complete the study.

• Allergy to any of the investigational medicinal products or their components.