A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer

Sponsor

West China Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05430737

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Stereotactic body radiotherapy (SBRT) has emerged as an effective and safe treatment for low and intermediate-risk prostate cancer(PCa). However, there is no study that has investigated the effectiveness and safety of SBRT with pelvic radiation and gross target volume(GTV) boost for high-risk prostate cancer patients yet. The investigators designed a phase II clinical study of SBRT with pelvic radiation and GTV boost based on mpMRI in patients with high-risk prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Stereotactic Body Radiotherapy High-risk Efficacy Safety	Radiation: stereotactic body radiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stereotactic body radiotherapy Long-term ADT of 2-3years were administered. Neoadjuvant ADT within 6 months was allowed.Then patients with high-risk prostate cancer recieve stereotactic body radiotherapy with pelvic radiation and GTV boost based on multiparameter magnetic resonance image.	Radiation: stereotactic body radiotherapy The radiation dose to the primary tumor was 40 or 45 Gy in five fractions according to the clinical determination of the radiologist. The dose to the positive lymph nodes and the prostate and seminal vesicles was 37.5Gy in five fraction. And internal iliac, external iliac, obturator, and presacral pelvic drainage regions received 25 Gy/5f, simultaneously. The treatment was delivered every other day. The volumetric modulated arc radiotherapy (VMAT) or intensity-modulated radiotherapy (IMRT) was used to complete treatment. Image-guided radiotherapy(IGRT) was performed for every treatment.

Arm

Intervention/Treatment

Experimental: stereotactic body radiotherapy

Long-term ADT of 2-3years were administered. Neoadjuvant ADT within 6 months was allowed.Then patients with high-risk prostate cancer recieve stereotactic body radiotherapy with pelvic radiation and GTV boost based on multiparameter magnetic resonance image.

Radiation: stereotactic body radiotherapy

The radiation dose to the primary tumor was 40 or 45 Gy in five fractions according to the clinical determination of the radiologist. The dose to the positive lymph nodes and the prostate and seminal vesicles was 37.5Gy in five fraction. And internal iliac, external iliac, obturator, and presacral pelvic drainage regions received 25 Gy/5f, simultaneously. The treatment was delivered every other day. The volumetric modulated arc radiotherapy (VMAT) or intensity-modulated radiotherapy (IMRT) was used to complete treatment. Image-guided radiotherapy(IGRT) was performed for every treatment.

Outcome Measures

Primary Outcome Measures

biochemical relapse-free survival [three months]
2-years biochemical relapse-free survival

Secondary Outcome Measures

the incidence rate of acute toxicity [every week]
the incidence rate of toxicity in 90 days
the incidence rate of late toxicity [three months]
the incidence rate of toxicity after 90 days
patient-reported quality of life [three months]
patient-reported quality of life using European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30(EORTC QLQ C30) .The The minimum and maximum values of EORTC QLQ C30 are 0 and 100,respectively.Higher scores for functional and overall health areas of EORTC QLQ C30 indicate better functional status and quality of life, and higher scores for symptom areas indicate more symptoms or problems.
symptom score [three months]
Symptom score using the International Prostatic System Score (IPSS) .The minimum and maximum values of IPSS are 0 and 35,respectively.A higher score of IPSS means a poorer quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years or older
pathologically confirmed high-risk (T3a or Gleason score ≥ 8 or a PSA > 20 ng/ml) prostate cancer
a WHO performance status 0-1
history of neoadjuvant androgen deprivation therapy(ADT) within 6 months before enrollment
Patients with pelvic positive lymph node were also included in our study

Exclusion Criteria:

distant metastasis
history of neoadjuvant ADT over 6 months before enrollment
history of definitive treatment for prostate cancer such as radical prostatectomy
history of pelvic irradiation; prostate volume≥100 cm3

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China, SiChuan	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

West China Hospital

Investigators

Principal Investigator: xin wang, China, SiChuan West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wang Xin, Professor, West China Hospital

ClinicalTrials.gov Identifier:

NCT05430737

Other Study ID Numbers:

SBRT-PCa-001

First Posted:

Jun 24, 2022

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jun 24, 2022