Localized Prostate CancerNCT06325774
Radical Hypofractionated Radiotherapy for Localized Prostate Cancer
A study testing Hypofractionated radiation therapy in people with Localized Prostate Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer. Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer
- What is being tested?
- Hypofractionated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old;
- European Cooperative Oncology Group score(ECOG):≤ 2;
- Patients with pathologically diagnosed prostate cancer;
- Clinical stage was cTanyN0M0 any Gleason / ISUP group;
- Expected survival time >5 years;
- The patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy;
- Patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options;
Who cannot join
- Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;
- a previous history of pelvic and abdominal radiotherapy;
- Prior hormonal therapy (castration or antiandrogen);
- Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis;
- Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;
- Patients with contraindications related to radiotherapy;
- Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;
- Patients unable to provide written informed consent or demonstrate poor treatment compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai, Shanghai Municipality, 200433
Huojun Zhang, M.D., +8613311732399, chyyzhj@163.com
Huojun Zhang, M.D.
About this study
Official title: Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial
The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.
Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.
Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.
Read the detailed description
The present study will be conducted as a prospective, open-label, single-arm clinical trial.
The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years.
The primary endpoints of the study are the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).
- Conditions
- Localized Prostate Cancer
- Being tested
- Hypofractionated radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiation therapyRadiation
54 Gy in 15 daily fractions of 3.6 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiotherapy | Experimental | Hypofractionated Radiotherapy over 3 weeks. Receives: Radiation: Hypofractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
RTOG / EORTC scale, Common Terminology Criteria for Adverse Events (CTCAE) 5.0, erectile dysfunction.
Measured: 5 years
Secondary outcomes (6)
biochemical progression-free survival (bPFS)
The definition of biochemical failure is a PSA measurement ≥ PSA nadir + 2 ng/mL where nadir is the lowest post-RT PSA value.Time to biochemical failure is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk).
Measured: 5 years
local progression-free-survival(LPFS)
Response evaluation criteria in solid tumor（RECIST）1.1:To determine the outcome of treatment for solid tumors,The efficacy according the diameter of the lesion could be divided into complete response（CR），partial response（PR）,stable disease（SD）and progressive disease（PD）.
Measured: 5 years
distant metastasis free survival(DMFS)
Distant metastasis (failure) is defined as radiographic evidence of hematogenous spread evaluated by bone scan, CT, or MRI. Time to distant metastasis is defined as time from randomization to the date of first distant metastasis, last known follow-up (censored), or death without local recurrence (competing risk).
Measured: 5 years
Overall survival (OS)
Overall survival time is defined as time from registration/randomization to the date of death (failure) from any cause or last known follow-up (censored).
Measured: 5 years
Quality of life (QoL)
Expanded Prostate Cancer Index (EPIC-26)：The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL.
Measured: 5 years
Physical Activity Rank Scale-3 (ARS-3)
To assess the physical activity rank.The scale was compiled by Japanese psychologist KIMIO HASHIMOTO and introduced and revised by Liang Deqing from Wuhan Physical Education University. There are only 3 items in this scale, which adopts 5 grades from 1 to 5, and examines the level of physical activity from 3 aspects: intensity, time and frequency of participating in physical activity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- More trials run by Changhai 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325774
- Sponsor's protocol ID
- Changhai HHospital
- Status last verified
- Aug 2024
- First submitted
- 16 Mar 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.
Publications
Liang Y, Zhang W, Zhao X, Zhang H. Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial. Future Oncol. 2025 May;21(12):1483-1488. doi: 10.1080/14796694.2025.2489340. Epub 2025 Apr 21.
PubMed 40257456
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06325774
- Acronym / sponsor ID
- Changhai HHospital
- Conditions
- Localized Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 22 Mar 2024 (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.
The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.
Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.
Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.
Detailed description
The present study will be conducted as a prospective, open-label, single-arm clinical trial.
The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years.
The primary endpoints of the study are the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiotherapy | Experimental | Radiation: Hypofractionated radiation therapyHypofractionated Radiotherapy over 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: ≥18 years old;
- European Cooperative Oncology Group score(ECOG):≤ 2;
- Patients with pathologically diagnosed prostate cancer;
- Clinical stage was cTanyN0M0 any Gleason / ISUP group;
- Expected survival time >5 years;
Key exclusion criteria (8 listed)
- Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;
- a previous history of pelvic and abdominal radiotherapy;
- Prior hormonal therapy (castration or antiandrogen);
- Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis;
- Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;
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 |
|---|---|---|
| Hypofractionated radiation therapy54 Gy in 15 daily fractions of 3.6 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. | Radiation | Hypofractionated Radiotherapy |
Primary outcome
Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
Time frame: 5 years
RTOG / EORTC scale, Common Terminology Criteria for Adverse Events (CTCAE) 5.0, erectile dysfunction.
6 secondary outcomes
biochemical progression-free survival (bPFS)
Time frame: 5 years
local progression-free-survival(LPFS)
Time frame: 5 years
distant metastasis free survival(DMFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Quality of life (QoL)
Time frame: 5 years
Physical Activity Rank Scale-3 (ARS-3)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Derived from this study: PubMed 40257456Liang Y, Zhang W, Zhao X, Zhang H. Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial. Future Oncol. 2025 May;21(12):1483-1488. doi: 10.1080/14796694.2025.2489340. Epub 2025 Apr 21.
- Individual participant dataSharing planned: Yes. Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated radiation therapy in people with Localized Prostate Cancer, run by Changhai 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huojun Zhang (021-31162222, huojunzh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06325774, which also lists 1 linked publication.
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 26 Aug 2024.