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Adjuvant therapy combine with androgen suppression and docetaxel for high risk prostate cancer patients post-prostatectomy:A single arm study

Adjuvant chemotherapy combine with androgen suppression therapy for high risk prostate cancer patients post-prostatectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016445
Enrollment
Unknown
Registered
2018-06-01
Start date
2018-08-01
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Prostate cancer

Interventions

Case series:adjuvant therapy combine with androgen suppression and docetaxel

Sponsors

The First Affiliated Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged=80 years; 2. ECOG=1 and life expectance more than 10 years . 3. Pathologically proven diagnosis of adenocarcinoma of the prostate gland at the time of prior radical prostatectomy meeting one of the following combinations: (1) Pathologic Gleason = 8 and = pT3b classification; (2) Pelvic lymph node metastases and any pT classification; (3) pT4 classification. 4. Enrollment must occur within 3 months from radical prostatectomy; 5. There are some important things (1) Hemoglobin = 9.0 g/dl; (2) Absolute neutrophil count (ANC) = 1,500 cells/mm3; (3) Platelets = 100,000 cells/mm3; (4) Serum potassium =3.5mmol/L; (5) ALT, AST= 1.5x institutional upper normal limits; total bilirubin =1.5x institutional upper normal limits; (6) Serum albumin =30g/L; 6. Patient must provide study-specific informed consent prior to study entry.

Exclusion criteria

Exclusion criteria: 1. Bone metastate, liver,brain or other viscera metastate by radiological evidence; 2. Prior invasive malignancy or prior systemic chemotherapy or biological therapy for the prostate cancer; 3. Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months;Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; virus hepatitis or chronic hepatic disease;Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; 4. Prior allergic reaction to the study drug(s) involved in this protocol; 5. Patient participated in other drug clinical trial within one month prior to the first use of chemotherapy,.(If the previous drug had a long half-life, there would be at least five times as much washout time before the first study was used as the previous study.)

Design outcomes

Primary

MeasureTime frame
PSA;

Secondary

MeasureTime frame
imageological examination;Bone ECT Scan;

Countries

China

Contacts

Public ContactShuo WANG

The First Affiliated Hospital of Zhejiang University

Shuowang11@zju.edu.cn+86 13336088887

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026