TreatmentNCT04599686
Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
A study testing ADT and SBRT in people with Treatment, run by Changhai Hospital at 1 site in China.
Trial summary
The aim of this study is to test the safety and feasibility of SBRT without ADT in oligometastatic prostate cancer in patients for whom the standard treatment is ADT, and to further explore how long only radiotherapy for oligometastases can prolong biochemical progression-free survival (bPFS). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Treatment
- What is being tested?
- ADT and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2022to 1 Oct 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 80 years old
- Histologically confirmed adenocarcinoma of the prostate
- Prostate cancer treated with curative intent (radical prostatectomy, primary radiotherapy, or a combination of both)
- Ga-68 prostate-specific membrane antigen (PSMA) PET/CT evidence of one to three metastases (bone or lymph node) within 6 weeks of enrolment, if the position of oligometastases is judged by the doctor to be in the same radiotherapy area, the number of metastases can be appropriately increased to 5
- Without ADT treatment
- PSA< 50ng/ml
- ECOG performance status 0-2
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
Who cannot join
- Any previous or ongoing treatment of oligometastases including radiotherapy, ADT, chemotherapy, focal treatment, etc.
- Unstable lesions with spinal or long bone metastases
- A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI
- 4 metastases, or if the metastases are in the same radiotherapy area, ≥6 metastases
- Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate
- Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc.
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- Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, etc.
- Patients who have participated in other clinical trials for less than three months
- Unsuitable to participate in this clinical trial judged by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai, Shanghai Municipality, 200433
Huojun Zhang, M.D., 021-31162222, chyyzhj@163.com
Huojun Zhang, M.D.
About this study
Official title: Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial
The aim of this study is to test the safety and feasibility of SBRT without ADT in oligometastatic prostate cancer in patients for whom the standard treatment is ADT, and to further explore how long only radiotherapy for oligometastases can prolong biochemical progression-free survival (bPFS). In this study, men with oligometastatic prostate cancer lesions will be randomized (1:1) to ADT versus SBRT. Within 6 weeks of the oligometastases diagnosis, ADT or SBRT (30-50Gy with 3-5 fractions) will be administered.
Read the detailed description
The oligometastatic disease state is an increasingly recognized phenomenon in prostate cancer. Ga-68 PSMA PET/CT has high accuracy in the diagnosis metastases from prostate cancer. In this protocol, pretreatment Ga-68 PSMA PET/ CT shall be performed in all patients.
ADT is considered standard of care treatment for advanced prostate cancer. But hormonal therapy can have side effects that greatly trouble men and lead to castration-resistant prostate cancer (CRPC). Any effort to delay the start of hormonal therapy would be an advantage to the patient. Stereotactic body radiation therapy (SBRT) is highly focused radiation, given in a very dose intensive fashion and delivered in usually less than one week. SBRT has been shown to be very effective on bone or lymph nodes metastases. Therefore, we are studying the safety and feasibility of SBRT on patients with five or fewer prostate cancer bone or lymph nodes metastases to determine if we can stall the use of hormonal therapy and/or prevent other site metastases from developing elsewhere in the body.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADTDrug
On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.
SBRTRadiation
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).
| Study group | Role | What they receive |
|---|---|---|
| ADT | Active comparator | Evaluating men with oligometastatic prostate cancer lesions randomized to ADT. Receives: Drug: ADT |
| SBRT | Experimental | Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT). Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year ADT-free survival of the experimental group
To assess ADT-free survival of the experimental group
Measured: Assessment ADT-free survival of the experimental group at 1 year
The Probability of Radiotherapy-related Toxicity
Radiotherapy-related complications
Measured: Assessment Toxicity at 1 year
The time from inception of the study to castration-resistant prostate cancer (CRPC)
the time from inception of the study to castration-resistant prostate cancer (CRPC)
Measured: Assessment at 1 year
Secondary outcomes (3)
1-year Efficacy Biochemical Progression-free Survival (bPFS)
Biochemical Progression-free Survival (bPFS)
Measured: 1 year
1-year Local Progression-Free-Survival(LPFS)
Local Progression-Free-Survival(LPFS)
Measured: Assessment at 1 year
1-year Distant Metastasis Free Survival(DMFS)
Distant Metastasis Free Survival(DMFS)
Measured: Assessment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start11 Sep 2022 (estimated)
- Primary completion11 Nov 2022 (estimated)
- Study completion1 Oct 2025 (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 TreatmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT04599686
- Sponsor's protocol ID
- Changhai Ho
- Status last verified
- Dec 2021
- First submitted
- 10 Oct 2020
- Last updated
- 11 Aug 2022
- 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
Zhao X, Wang T, Ye Y, Li J, Gao X, Zhang H. Stereotactic body radiotherapy (SBRT) versus androgen deprivation therapy (ADT) for oligometastatic prostate cancer: protocol for a prospective randomised control clinical trial. BMJ Open. 2022 Sep 30;12(9):e051371. doi: 10.1136/bmjopen-2021-051371.
PubMed 36180115
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT04599686
- Acronym / sponsor ID
- Changhai Ho
- Conditions
- Treatment
- Keywords
- SBRT, Oligometastatic Prostate Cancer, Feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 11 Sep 2022 (estimated)
- Primary completion
- 11 Nov 2022 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Oct 2020 (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 study is to test the safety and feasibility of SBRT without ADT in oligometastatic prostate cancer in patients for whom the standard treatment is ADT, and to further explore how long only radiotherapy for oligometastases can prolong biochemical progression-free survival (bPFS). In this study, men with oligometastatic prostate cancer lesions will be randomized (1:1) to ADT versus SBRT. Within 6 weeks of the oligometastases diagnosis, ADT or SBRT (30-50Gy with 3-5 fractions) will be administered.
Detailed description
The oligometastatic disease state is an increasingly recognized phenomenon in prostate cancer. Ga-68 PSMA PET/CT has high accuracy in the diagnosis metastases from prostate cancer. In this protocol, pretreatment Ga-68 PSMA PET/ CT shall be performed in all patients.
ADT is considered standard of care treatment for advanced prostate cancer. But hormonal therapy can have side effects that greatly trouble men and lead to castration-resistant prostate cancer (CRPC). Any effort to delay the start of hormonal therapy would be an advantage to the patient. Stereotactic body radiation therapy (SBRT) is highly focused radiation, given in a very dose intensive fashion and delivered in usually less than one week. SBRT has been shown to be very effective on bone or lymph nodes metastases. Therefore, we are studying the safety and feasibility of SBRT on patients with five or fewer prostate cancer bone or lymph nodes metastases to determine if we can stall the use of hormonal therapy and/or prevent other site metastases from developing elsewhere in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT | Active comparator | Drug: ADTEvaluating men with oligometastatic prostate cancer lesions randomized to ADT. |
| SBRT | Experimental | Radiation: SBRTEvaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 80 years old
Key exclusion criteria (9 listed)
- Any previous or ongoing treatment of oligometastases including radiotherapy, ADT, chemotherapy, focal treatment, etc.
- Unstable lesions with spinal or long bone metastases
- A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI
- Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate
- Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc.
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 |
|---|---|---|
| ADTOn the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT. | Drug | ADT |
| SBRTEvaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions). | Radiation | SBRT |
Primary outcome
1-year ADT-free survival of the experimental group
Time frame: Assessment ADT-free survival of the experimental group at 1 year
To assess ADT-free survival of the experimental group
The Probability of Radiotherapy-related Toxicity
Time frame: Assessment Toxicity at 1 year
Radiotherapy-related complications
The time from inception of the study to castration-resistant prostate cancer (CRPC)
Time frame: Assessment at 1 year
the time from inception of the study to castration-resistant prostate cancer (CRPC)
3 secondary outcomes
1-year Efficacy Biochemical Progression-free Survival (bPFS)
Time frame: 1 year
1-year Local Progression-Free-Survival(LPFS)
Time frame: Assessment at 1 year
1-year Distant Metastasis Free Survival(DMFS)
Time frame: Assessment at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Derived from this study: PubMed 36180115Zhao X, Wang T, Ye Y, Li J, Gao X, Zhang H. Stereotactic body radiotherapy (SBRT) versus androgen deprivation therapy (ADT) for oligometastatic prostate cancer: protocol for a prospective randomised control clinical trial. BMJ Open. 2022 Sep 30;12(9):e051371. doi: 10.1136/bmjopen-2021-051371.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADT and SBRT in people with Treatment, 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 8 inclusion and 9 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 11 Aug 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 Huojun Zhang, PhD (021-31162222, chyyzhj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year ADT-free survival of the experimental group (time frame: Assessment ADT-free survival of the experimental group at 1 year). The study lists 3 primary outcomes in all. 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 NCT04599686, 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 11 Aug 2022.