mHSPC

4

Review clinical trials related to mHSPC. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer

The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are: 1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and 2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose. Participants will: * Be randomised to take full dose (100%) of ARPI or half dose (50%) of ARPI. * Receive standard of care ADT. * Be on treatment for approximately 3 years according to standard of care. * Have clinic assessments and visits in clinic or remotely, as per their treating hospital's standard routine local practice in line with standard of care. Additional visits are not expected. * Complete quality of life questionnaires at week 0 (pre-treatment) and weeks 4, 16, 32, 48 and 64. * Keep a diary of their symptoms. Translational research samples will be collected as follows: * Blood samples at week 0 (pre-treatment) and weeks 24, 32, 48 and at disease progression. * Urine samples at week 0 (pre-treatment) and week 24 and at disease progression. * FFPE Tumour: Routinely collected diagnostic blocks. The duration of follow-up is approximately 3 years after the last patient is recruited (minimum follow-up is 3 years; maximum follow-up is approximately 6 years for the the first patient recruited) and the trial is expected to complete August 2032 (Last Patient Last Visit).

Participants needed: 1,500
Trial details
Phase: Phase 3Age: 18+Biological sex: MaleType: InterventionalSponsor: University College, LondonUpdated: Aug 7, 2026
Eligibility criteria

Adult males (male sex at birth) aged 18 years or older [+4]

Pathology other than adenocarcinoma consistent with small cell, ductal, sarcomat... [+8]

Status: Not yet recruiting

Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC

This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients. The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA\< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.

Participants needed: 109
Trial details
Phase: Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: Yonghong LiUpdated: Mar 31, 2026Locations: 2
Eligibility criteria

Written informed consent [+6]

LHRH agonist/antagonists started more than 12 weeks before before the initiation... [+3]

Status: Not yet recruiting

Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer

This study is a single-centre, randomised, paired 24-week intervention dosing trial. Its purpose is to evaluate the safety profile and efficacy of the investigational drug in subjects with metastatic hormone-sensitive prostate cancer receiving oral LC-K76 treatment. Following a screening period not exceeding three weeks, subjects will enter a one- to two-week matching and randomization phase. Subsequently, subjects will be assigned to receive the study drug for a 24-week treatment period, followed by a 24-week follow-up period.

Participants needed: 40
Trial details
Phase: Early Phase 1Age: 18-85Biological sex: MaleType: InterventionalSponsor: Shanghai Changzheng HospitalUpdated: Feb 5, 2026Locations: 1
Eligibility criteria

Male, aged ≥ 18 years. [+7]

Lack of pathological evidence for prostate cancer diagnosis. [+12]

Status: Not yet recruiting

Minimal Residual Disease Used in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer

This study is a prospective, single-center, observational study of patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC). Minimal residual disease (MRD) detection is used to investigate the actual efficacy responses of mHSPC patients with different gene mutation characteristics to treatment regimens. Factors influencing efficacy are further analyzed to provide a basis for the precise clinical diagnosis and treatment of mHSPC patients.

Participants needed: 50
Trial details
Age: 18-85Biological sex: MaleType: ObservationalSponsor: Anhui Medical UniversityUpdated: Jan 12, 2026
Eligibility criteria

Aged 18 years and younger than 85 years; [+8]

(1) Patients diagnosed with neuroendocrine/small cell prostate cancer by patholo...