The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy

NCT06505278 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023-FXY-183
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the impact of medication timing adjustment on the effect of novel hormonal therapy (NHT) agents in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The half of the patients will receive NHT agents in the morning, and the other half will receive NHT agents in the evening.

Conditions

Prostate Cancer

Keywords

Circadian Rhythm; Metastatic Hormone-Sensitive Prostate Cancer; Medication Timing; Novel Hormonal Therapy

Outcome Measures

Primary Outcomes (1)

• PSA response rate defiend as the proportion of participants whose prostate specific antigen (PSA) decreases by more than 90% from baseline after three months of treatment

  PSA is a critical indicator for assessing the efficacy of prostate cancer treatment; typically, a lower PSA value suggests better therapeutic outcomes. A second PSA measurement is confirmed after 3 weeks from week 12.

  Baseline and Week 12

Secondary Outcomes (9)

• Circulating tumor cell (CTC) clearance rate defiend as the proportion testing negative for circulating tumor cell (CTC) at week 12 in patients with a baseline CTC count of ≥1

  Baseline and Week 12

• Clinical benefit rate (CBR) defiend as the proportion of patients comfirming partial response (PR), complete response (CR), or stable disease (SD).

  Through study completion, an average of 18 months

• Objective response rate (ORR) defiend as the proportion of participants confirming partial response (PR) or complete response (CR)

  Through study completion, an average of 18 months

• Duration of relief defiend from the first assessment of complete response (CR) or partial response (PR) until the detection of disease progression (PD)

  From CR or PR to PD, up to 18 months

• Time to achieve objective relief defiend from randomization until achieving complete response (CR) or partial response (PR).

  From start of treatment to CR or PR, up to 18 months

Study Arms (2)

Night medication group

EXPERIMENTAL

Participants receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide between 10:00 pm and 12:00 pm.

Drug: Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening

Daytime medication group

NO INTERVENTION

Participants receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide between 7:00 am and 9:00 am.

Interventions

Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening DRUG

Participants receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide between 10:00 pm and 12:00 pm in the evening.

Night medication group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily participate in the study and have signed a written informed consent form (ICF);
• Male patients aged 18 to 75 years (inclusive) at the time of signing the ICF;
• Histologically or cytologically confirmed prostate cancer, without prior novel hormonal therapy (NHT) or chemotherapy;
• Assessed as having metastatic hormone-sensitive prostate cancer (mHSPC), defined as: histologically or cytologically confirmed prostate cancer with distant metastases (beyond regional lymph nodes) detected by bone scan, MRI, CT, PET/CT, or pathological examination, and who have not received hormonal therapy or chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1;
• Normal routine blood count and liver and kidney functions, expected to tolerate treatment for mHSPC;
• Expected survival period ≥ 12 weeks.
• Agreement to sign the ICF.

You may not qualify if:

• Patients currently receiving other systemic anticancer treatments (such as chemotherapy and/or immunotherapy);
• Patients who have undergone organ transplantation within the past three months;
• Patients with active, known, or suspected autoimmune diseases; or those testing positive for hepatitis B virus, hepatitis C virus, or HIV indicating acute or chronic infection;
• Patients with severe life-threatening diseases;
• Patients who have not signed the ICF;
• Other conditions deemed by the researchers to make the patient unsuitable for participation in the trial.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yonghong Li, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghong Li, M.D.

CONTACT

13711376697; liyongh@sysucc.org.cn

Jun Wang, M.D.

CONTACT

13631448801; wangjun2@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)