Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• ECOG performance status 0-2.

• Pathologically confirmed prostate cancer and completion of radical prostatectomy.

• Postoperative pathological staging pT 3a, pT 3b, pT 4, surgical margins (+) or N1; or serum PSA ≥0.1ng/ml at 6 weeks postoperatively; or serum PSA \<0.1ng/ml at 6 weeks postoperatively, with two consecutive persistently elevated PSA (≥0.1ng/ml) without signs of metastasis on clinical imaging (whole-body bone scan (ECT), magnetic resonance imaging (MRI), 68Ga PSMA PET/CT, etc.) .

• Expected survival time \>5 years.

• Voluntarily accepted this experimental study protocol after being informed of the available treatment options.

Locations
Other Locations
China
The First Affiliated Hospital of Naval Medical University
RECRUITING
Shanghai
Contact Information
Primary
Huojun Zhang, PhD
huojunzh@163.com
021-31162222
Backup
Xianzhi Zhao, PhD
zhxzh0007@163.com
021-31162222
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 9
Treatments
Experimental: adjuvant hypofractionated radiotherapy
Patients after radical prostatectomy with high-risk pathological factors will receive hypofractionated post-prostatectomy radiotherapy in 15 fractions.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov