MRDNCT07112612

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

An observational study of MRD and Prostate Cancer, run by Anhui Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 85 years, men only
Conditions the study is for: MRD, Prostate Cancer, mHSPC
How many people: 50 participants
Where: No sites listed yet
Study dates: 30 Jan 2026to 30 Apr 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
Men only
No healthy volunteers
Adult, Older adult

Study population: patients with metastatic hormone-sensitive prostate cancer

Who may be able to join

Aged 18 years and younger than 85 years;
Patients diagnosed with prostate acinar adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma by pathological histology;
Patients with clear distant metastases found by imaging (in accordance with RECIST criteria);
Patients with locally advanced (N1) and metastatic (M1) prostate cancer at diagnosis.
Patients who have not received endocrine therapy or other systemic anti-tumor treatments in the past;
ECOG score of 0-2 points, with an expected survival period of more than 6 months;

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Patients with normal organ function;
Routine blood test (no blood transfusion or blood products within 14 days):
Hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L (1500 /mm3); Platelet count (PLT) ≥ 75×109/L; White blood cell count (WBC) ≥ 3×109/L;
Biochemical examination:
Total bilirubin (TBIL) ≤ upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN; Creatinine clearance (CCr) ≥ 30ml/min; (Cockcroft-Gault formula);
Coagulation function: prothrombin international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) < 4 seconds;
Patients agree to sign informed consent and are able to attend scheduled study visits, provide clinical information, and cooperate with other study procedures.

Who cannot join

(1) Patients diagnosed with neuroendocrine/small cell prostate cancer by pathological histology; (2) No clear distant metastasis was found by imaging (in accordance with RECIST criteria); (3) Patients with a history of previous treatment: including neoadjuvant and adjuvant therapy; (4) The samples submitted for examination failed to meet the quality control requirements.
Patients with combined endocrine, metabolic system diseases or other serious digestive system diseases; (6) Patients with combined chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency and other diseases; (7) Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (8) Patients with a history of other malignant tumors; (9) Patients enrolled in other clinical trials; (10) Patients unable to obtain the clinical information required for the study (e.g., patients lost to follow-up); (11) Other situations that the researchers consider unsuitable for enrollment.

About this study

Official title: Application of Personalized Minimal Residual Disease in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer

Read the detailed description

This is a prospective, single-center, observational study designed to observe the therapeutic response of metastatic hormone-sensitive prostate cancer(mHSPC) patients with different gene mutation characteristics to treatment regimens. The study will recruit 50 mHSPC patients from the First Affiliated Hospital of Anhui Medical University and design a personalized minimal residual disease (MRD) kit based on the data of the biopsy before treatment. The blood routine, biochemical indicators, sex hormone levels, prostate multi-parameter magnetic resonance imaging (Mp-MRI), quantitative whole-body bone examination, and PSMA-PET-CT examination of the study cohort patients will be recorded. During the treatment, MRD will be tested every three months, and the MRD level, blood routine, biochemical markers, sex hormone levels, and PSA levels; patients in the study cohort will undergo prostate multiparametric magnetic resonance imaging (Mp-MRI) and quantitative whole-body skeletal examination every three months. If PSA progression occurs during follow-up, the PSA recheck frequency will be customized. This prospective, observational study will explore the response efficiency of mHSPC patients with different gene mutation types to treatment regimens through MRD detection, analyze the relevant factors affecting the efficacy, and provide a basis for the precise clinical diagnosis and treatment of mHSPC patients.

Conditions: MRD, Prostate Cancer, mHSPC
Keywords: minimal residual disease, MRD, PCa
Medical subject headings: Prostatic Neoplasms, Neoplasm, Residual

What is being measured

The primary outcome is the main question the study is designed to answer.

minimal residual disease(MRD) positive rate
The probability of patients in the study cohort testing positive using the minimal residual disease (MRD) test kit.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202630 Apr 2027

First posted8 Aug 2025
Study start30 Jan 2026 (estimated)
Primary completion30 Dec 2026 (estimated)
Study completion30 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MRDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07112612
Sponsor's protocol ID: PJ 2024-11-47
Status last verified: Jan 2026
First submitted: 2 Aug 2025
Last updated: 12 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
Not yet recruitingPhase 2
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma

All MRD trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Personalized Minimal Residual Disease in Predicting Therapeutic Efficacy in Metastatic Hormone-sensitive Prostate Cancer
ClinicalTrials.gov ID: NCT07112612
Acronym / sponsor ID: PJ 2024-11-47
Conditions: MRD, Prostate Cancer, mHSPC
Keywords: minimal residual disease, MRD, PCa
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Anhui Medical UniversityUniversity, hospital or other
Study start: 30 Jan 2026 (estimated)
Primary completion: 30 Dec 2026 (estimated)
Study completion: 30 Apr 2027 (estimated)
First posted: 8 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 to 85 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients with metastatic hormone-sensitive prostate cancer

Key inclusion criteria (13 listed)

Aged 18 years and younger than 85 years;
Patients diagnosed with prostate acinar adenocarcinoma, ductal adenocarcinoma, or intraductal carcinoma by pathological histology;
Patients with clear distant metastases found by imaging (in accordance with RECIST criteria);
Patients with locally advanced (N1) and metastatic (M1) prostate cancer at diagnosis.
Patients who have not received endocrine therapy or other systemic anti-tumor treatments in the past;

Key exclusion criteria (2 listed)

(1) Patients diagnosed with neuroendocrine/small cell prostate cancer by pathological histology; (2) No clear distant metastasis was found by imaging (in accordance with RECIST criteria); (3) Patients with a history of previous treatment: including neoadjuvant and adjuvant therapy; (4) The samples submitted for examination failed to meet the quality control requirements.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

minimal residual disease(MRD) positive rate
Time frame: baseline
The probability of patients in the study cohort testing positive using the minimal residual disease (MRD) test kit.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Individual participant dataSharing planned: No

Related trials for MRD

RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
Not yet recruitingPhase 2
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of MRD and Prostate Cancer, run by Anhui Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

minimal residual disease(MRD) positive rate (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07112612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.