Prostate CancerNCT05430737
A Phase II Clinical Study of Stereotactic Radiation Therapy in Patients With High-risk Prostate Cancer
A study testing stereotactic body radiotherapy in people with Prostate Cancer and Stereotactic Body Radiotherapy, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years, men only
- Conditions the study is for
- Prostate Cancer, Stereotactic Body Radiotherapy, High-risk
- What is being tested?
- stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, SiChuan
Chengdu, Sichuan, 610041
xin Wang, PhD/MD, +86 28 85423609, wangxin213@sina.com
fang Wang, 17342338589, 17342338589@163.com
About this study
Official title: A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer
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.
- Conditions
- Prostate Cancer, Stereotactic Body Radiotherapy, High-risk, Efficacy, Safety
- Being tested
- stereotactic body radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| stereotactic body radiotherapy | Experimental | 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. Receives: Radiation: stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical relapse-free survival
2-years biochemical relapse-free survival
Measured: three months
Secondary outcomes (4)
the incidence rate of acute toxicity
the incidence rate of toxicity in 90 days
Measured: every week
the incidence rate of late toxicity
the incidence rate of toxicity after 90 days
Measured: three months
patient-reported quality of life
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.
Measured: three months
symptom score
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xin, West China Hospital
- Investigators
- xin wang, Principal investigator, China, SiChuan West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430737
- Sponsor's protocol ID
- SBRT-PCa-001
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Stereotactic Radiation Therapy Based on Multiparameter Magnetic Resonance Image in Patients With High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05430737
- Acronym / sponsor ID
- SBRT-PCa-001
- Conditions
- Prostate Cancer, Stereotactic Body Radiotherapy, High-risk, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stereotactic body radiotherapy | Experimental | Radiation: stereotactic body radiotherapyLong-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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic body radiotherapyThe 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. | Radiation | stereotactic body radiotherapy |
Primary outcome
biochemical relapse-free survival
Time frame: three months
2-years biochemical relapse-free survival
4 secondary outcomes
the incidence rate of acute toxicity
Time frame: every week
the incidence rate of late toxicity
Time frame: three months
patient-reported quality of life
Time frame: three months
symptom score
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xin wang principal investigator
China, SiChuan West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic body radiotherapy in people with Prostate Cancer and Stereotactic Body Radiotherapy, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xin wang, PhD/MD (+86 28 85423609, wangxin213@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical relapse-free survival (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.