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A prospective randomized controlled study of the efficacy and safety of androgen deprivation therapy combined with modified docetaxel chemotherapy in metastatic prostate cancer patients with poor tolerance to chemotherapy

A prospective randomized controlled study of the efficacy and safety of androgen deprivation therapy combined with modified docetaxel chemotherapy in metastatic prostate cancer patients with poor tolerance to chemotherapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046636
Enrollment
Unknown
Registered
2021-05-24
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Experimental Group:Androgen deprivation therapy combined with modified docetaxel chemotherapy
Control Group:Androgen deprivation therapy combined with standard docetaxel chemotherapy

Sponsors

The Seventh Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Sign the informed consent form voluntarily; 2.Definitely diagnosed as metastatic prostate cancer and the pathological type is adenocarcinoma or predominantly adenocarcinoma; 3.ECOG PS >= 2; 4.Return to the hospital regularly; 5.Can be followed up for at least 1 year.

Exclusion criteria

Exclusion criteria: 1.Chemotherapy contraindications (allergic to docetaxel; peripheral blood neutrophils (ANC) upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3.5xULN; left ventricular ejection fraction < 50%); 2.Had received neoadjuvant therapy before operation; 3.Combined with other malignant tumors; 4.Combined with severe cardiovascular, respiratory, liver, and kidney diseases or poor blood sugar control; 5.Combined with mental disorders; 6.Poor compliance; 7.With other clinical and laboratory conditions not suitable to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
Progression-free survival, PFS;

Secondary

MeasureTime frame
Overall survival, OS;Prostate specific antigen response rate;Pain relief rate;Incidence of side effects;Quality of life;

Countries

China

Contacts

Public ContactPang Jun

The Seventh Affiliated Hospital, Sun Yat-Sen University

pangjun530@qq.com+86 18802044177

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026