Prostate Cancer (Post Prostatectomy)SMART-B01NCT07324798
Adaptive Radiotherapy for Genitourinary Cancers
A study testing adaptive RT in people with Prostate Cancer (Post Prostatectomy) and Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy), Bladder Cancer
- What is being tested?
- adaptive RT
- 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
- 1 Dec 2024to 31 Dec 2028
- 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
- Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors, clinically assessed as suitable for adaptive radiotherapy;
- Age ≥ 18 years;
- ECOG performance status score 0-2;
- No prior radiotherapy history within the current radiation field;
- No contraindications for MRI scanning;
- No contraindications for radiotherapy.
Who cannot join
- Patients with contraindications to radiotherapy;
- Patients unable to tolerate MRI or with contraindications to MRI scanning.
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
Cancer Hospital, National Cancer Center, CAMS & PUMC
Beijing, Beijing Municipality, 100021
Ning-Ning Lu, M.D., 861018611804268, ningninglu09@163.com
About this study
Official title: Prospective Study of siMultaneous Adaptive RadioTherapy for Local Boost for Prostate and Bladder Cancers (SMART-B01)
The goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. It will also learn about the safety and efficacy of adaptive boost. The main questions it aims to answer are:
Does adaptive boost lower the toxicities? Does adaptive boost maintain or improve the clinical efficacy?
Participants will:
Undergo adaptive boost on 1.5-Tesla MR-Linac Visit the clinic once every 2 weeks during RT, and every 3 months post-ART Keep a regular QOL questinnaire completion
- Being tested
- adaptive RT
- Keywords
- prostate cancer, bladder cancer, adaptive radiotherapy, post-prostatectomy, bladder-conserving treatment
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adaptive RTRadiation
Prostate cancer pts post-prostatectomy：95%PTVboost 7Gy/3.5Gy/2f，95%PTV 66Gy/2.0Gy/33f，w/o 95%PTVp 50Gy/2.0Gy/25f Bladder cancer pts with bladder-conserving txt：95%PGTV 18Gy/6.0Gy/3f，95%PTV 50Gy/2.0Gy/25f，w/o 95%PTVp 50Gy/2.0Gy/25f
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Pts will receive adaptive boost for clinically significant disease Receives: Radiation: adaptive RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT
Measured: 3-months post-RT
Secondary outcomes (11)
Quality-of-Life, general
general quality-of-life questionaaires as per EORTC QLQ-C30
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Local control
local control
Measured: 2-year
disease-free survival
disease-free survival
Measured: 2-year
Late toxicities
Late GU and GI toxicities as per RTOG scales
Measured: 2-year
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
GU quality-of-life questionaaires as per EORTC QLQ-NMIBC24
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
quality-of-life questionaaires as per EORTC QLQ- BLM30
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
quality-of-life questionaaires as per BCI
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
quality-of-life questionaaires as per FACT-BL
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
quality-of-life questionaaires as per FACT-P
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
quality-of-life questionaaires as per EPIC-26
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, sexual scales
quality-of-life questionaaires as per IIEF-5
Measured: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- 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
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324798
- Sponsor's protocol ID
- NCC-020503
- Acronym
- SMART-B01
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of siMultaneous Adaptive RadioTherapy for Local Boost for Prostate and Bladder Cancers (SMART-B01)
- ClinicalTrials.gov ID
- NCT07324798
- Acronym / sponsor ID
- SMART-B01 / NCC-020503
- Keywords
- prostate cancer, bladder cancer, adaptive radiotherapy, post-prostatectomy, bladder-conserving treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Jan 2026 (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 goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. It will also learn about the safety and efficacy of adaptive boost. The main questions it aims to answer are:
Does adaptive boost lower the toxicities? Does adaptive boost maintain or improve the clinical efficacy?
Participants will:
Undergo adaptive boost on 1.5-Tesla MR-Linac Visit the clinic once every 2 weeks during RT, and every 3 months post-ART Keep a regular QOL questinnaire completion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Radiation: adaptive RTPts will receive adaptive boost for clinically significant disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors, clinically assessed as suitable for adaptive radiotherapy;
- Age ≥ 18 years;
- ECOG performance status score 0-2;
- No prior radiotherapy history within the current radiation field;
- No contraindications for MRI scanning;
Key exclusion criteria (2 listed)
- Patients with contraindications to radiotherapy;
- Patients unable to tolerate MRI or with contraindications to MRI scanning.
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 |
|---|---|---|
| adaptive RTProstate cancer pts post-prostatectomy：95%PTVboost 7Gy/3.5Gy/2f，95%PTV 66Gy/2.0Gy/33f，w/o 95%PTVp 50Gy/2.0Gy/25f Bladder cancer pts with bladder-conserving txt：95%PGTV 18Gy/6.0Gy/3f，95%PTV 50Gy/2.0Gy/25f，w/o 95%PTVp 50Gy/2.0Gy/25f | Radiation | Experimental arm |
Primary outcome
Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT
Time frame: 3-months post-RT
11 secondary outcomes
Quality-of-Life, general
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Local control
Time frame: 2-year
disease-free survival
Time frame: 2-year
Late toxicities
Time frame: 2-year
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, sexual scales
Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
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 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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 adaptive RT in people with Prostate Cancer (Post Prostatectomy) and Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 6 inclusion and 2 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 7 Jan 2026. 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 Ning-Ning Lu, M.D. (861018611804268, ningninglu09@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT (time frame: 3-months post-RT). 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 7 Jan 2026.