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Radiotherapy of Primary Tumor and All Metastatic Lesions for Oligometastatic Prostate Cancer: a randomized controlled trial

Radiotherapy of Primary Tumor and All Metastatic Lesions for Oligometastatic Prostate Cancer: a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093031
Enrollment
Unknown
Registered
2024-11-27
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Prostate cancer

Interventions

Cohort A: Treatment group:prostate and metastatic full coverage radiotherapy group (TRT)
Cohort B: Control group:prostate radiotherapy group (PRT)

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) 18 -85 years old. 2) Pathologically confirmed prostate cancer, except small cell carcinoma or sarcoma, is allowed to contain partial neuroendocrine differentiation. 3) New generation imaging such as prostate specific membrane antigen (PSMA) PET=10 metastases. Non-regional lymph node metastasis was allowed. Pelvic lymph node metastases (N1) were allowed but not counted as metastases. The pelvis is divided into four parts according to anatomy: the left hip bone, the right hip bone, the sacrum, and the tailbone. If there are multiple metastases in each part, the total number of each part is 1. The following picture shows two metastases (left hip bone and sacrum). 4) Systemic therapy (endocrine therapy, chemotherapy, targeted therapy, and nuclide therapy) was allowed before enrollment, with the randomization time =3 months. 5) ECOG score 0-2. 6) Agree to join the group and sign the informed consent. 7) Can cooperate with radiotherapy position fixation and radiotherapy. 8) Able to cooperate with the completion of quality of life related questionnaires.

Exclusion criteria

Exclusion criteria: 1) External radiotherapy, brachytherapy and radical prostatectomy were performed on the primary site. 2) Hormone resistance stage (mCRPC). 3) Participants considered unsuitable for clinical trials by the researchers.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Complete PSA response rate;

Secondary

MeasureTime frame
Overall survival;Time to PSA Progression;Toxic side effects;Quality of life;Time to Next Intervention;

Countries

China

Contacts

Public ContactQi Xin

Peking University First Hospital

qixin0327@139.com+86 188 1053 4009

Outcome results

None listed

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