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A Phase II Trial of adjuvant moderate hypofractionation after radical prostatectomy

A Phase II Trial of adjuvant moderate hypofractionation after radical prostatectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102712
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Prostate cancer

Interventions

Observation group:None

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate and sign the informed consent form in writing; 2. Patients with limited radical prostatectomy with risk factors: pT3-4 / GS 8-10 points / tPSA >20ng/ml tumor, positive surgical margin (R1), pN; 3. Patients with biochemical recurrence or close to biochemical recurrence after radical resection of localized prostate: tPSA>0.1ng/ml; 4. Karl Fischer score>=80 points; 5. Estimated survival >=5 years; 6. Endocrine therapy is allowed.

Exclusion criteria

Exclusion criteria: 1. Pelvic lymph node recurrence, or distant metastasis; 2. There is a history of radiotherapy in the area to be irradiated; 3. Suffering from other primary malignant tumors at the same time; 4. Have serious comorbidities, such as hypertension, coronary heart disease, history of mental illness or severe allergies; 5. Refusal or inability to sign the informed consent form to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Late toxic and side effects of intestinal and urinary system;

Secondary

MeasureTime frame
Failure-free lifetime;Prostate-specific survival;Overall survival;Side effects of intestinal and urinary system;

Countries

China

Contacts

Public ContactLingling Meng

Chinese PLA General Hospital

mll301@126.com+86 138 1167 0794

Outcome results

None listed

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