Prostate CancerNCT04742972
Prostate PMSABR Study
A study testing SABR and SOC in people with Prostate Cancer, run by Darren Poon.
Trial summary
In this study, the investigator aim to evaluate the role of PMSA-PET guided SABR on progression free survival (PFS) in patients with oligoprogressive mCRPC with Enzalutamide. The potential improvement in PFS with SABR while continuing the initial-responding Enzalutamide is potentially benefiting to patients in terms… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SABR and SOC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2021to 16 Sep 2022
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of prostate adenocarcinoma
- Evidence of stage IV disease (as defined by AJCC criteria) on previous bone, CT, and/or MRI scan
- Ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (ie, surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit
- ECOG performance score 0-2
- Age ≥ 18
- History/physical examination within 2 weeks prior to registration
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- Able to sign informed-consent
- Patient with mCRPC who received Enzalutamide during the past 6-8 weeks and must have been delivered for a total of at least 3 months with an initial ≥50% decline of PSA from baseline.
- Documented disease progression with Enzalutamide as defined by PCWG3 with at least one of the followings:
- PSA progression: defined by PSA increase that is ≥ 25% and ≥ 2 ng/mL above the nadir. A minimum of 2 rising PSA levels with an interval of ≥ 1 week between each determination.
- Radiographic disease progression in soft tissue based on RECIST 1.1 criteria. Participants whose disease spread is limited to regional pelvic lymph nodes (N1) measuring at least 2 cm in short axis will be considered eligible.
- Radiographic disease progression in bone defined as appearance of 2 or more new bone lesions on bone scan
- A maximum of 5 extracranial metastases in any organ system (except brain), with ≤ 4 tumours within any given organ system, confirmed with PSMA PET-CT scan
- All sites of oligometastasis can be safely treated with SABR
- Adequate baseline organ function to allow SABR to all relevant targets
- Participants already receiving agents for the management of skeletal-related events (SREs) are allowed to continue with anti-bone resorptive therapy (including, but not limited to bisphosphonate or receptor activator of nuclear factor kappa ligand inhibitor) if on stable dose for more than 28 days prior to treatment arm assignment
Who cannot join
- Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
- Prior treatment with docetaxel, another chemotherapy agent or second generation hormonal therapy (e.g. abiraterone acetate or enzalutamide) for metastatic castration-resistant prostate cancer. Prior docetaxel, abiraterone acetate or enzalutamide for metastatic hormone-sensitive prostate cancer is allowed if ≥ 12 months elapsed from last dose of these treatments.
- PSA at inclusion >20 ng/ml
- Serum creatinine and total bilirubin > 3 times the upper limit of normal
- Liver Transaminases > 5-times the upper limit of normal
- Unstable angina and/or congestive heart failure requiring hospitalization, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
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- Patients with oligometastases that have been previously treated with SABR.
- Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. For patients with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease
- Clinical or radiological evidence of spinal cord compression or tumor within 1.5mm of spinal cord on MRI
- Malignant pleural effusion
- Malignant peritoneal disease
- Intra-cranial metastases
About this study
Official title: PSMA-PET Guided Stereotactic Ablative Body Radiotherapy for Oligometastasis in Metastatic Castration-resistant Prostate Cancer (mCRPC) With Progression on Enzalutamide (PMSABR Study)
In this study, the investigator aim to evaluate the role of PMSA-PET guided SABR on progression free survival (PFS) in patients with oligoprogressive mCRPC with Enzalutamide. The potential improvement in PFS with SABR while continuing the initial-responding Enzalutamide is potentially benefiting to patients in terms of overall disease control.
- Conditions
- Prostate Cancer
- Being tested
- SABR, SOC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABRRadiation
SABR is delivered to all sites of oligometastasis with continuation of Enzalutamide. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in SOC Arm.
SOCOther
Three options:
- Continuation of Enzalutamide
- Observation
- Switch to next line treatment
| Study group | Role | What they receive |
|---|---|---|
| SABR | Experimental | Not described Receives: Radiation: SABR |
| SOC | Placebo comparator | Not described Receives: Other: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 6-month progression-Free Survival rate
Measured: up to 2 years
Secondary outcomes (9)
Progression-Free Survival
Measured: 2 years
Time to progression
Measured: 2 years
Overall survival
Measured: 2 years
Local control rate of the SABR-treated oligometastasis at 6 months after SABR
Measured: up to 2 years
Local control rate of the SABR-treated oligometastasis at 6 months after SABR based on the PERCIST criteria
Measured: up to 2 years
QOL (EORTC QLQ-C30)
Measured: 2 years
Time to next systemic treatment
Measured: 2 years
The number of participants with treatment-related adverse event as assessed by CTCAE v4.0
Measured: 2 years
The proportion of patients in both arms who have AR-V7 (CTCs)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start25 Feb 2021
- Primary completion15 Sep 2022
- Study completion16 Sep 2022
Why it stopped: The lack of well-defined oligometastasis, high disease burden in mCRPC and high sensitivity of PSMA-PET scan, PMSABR study was made with high ambition and the assumption on recruitment was found to be invalid.
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darren Poon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darren Poon, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742972
- Sponsor's protocol ID
- PST010
- Status last verified
- Dec 2022
- First submitted
- 3 Feb 2021
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-PET Guided Stereotactic Ablative Body Radiotherapy for Oligometastasis in Metastatic Castration-resistant Prostate Cancer (mCRPC) With Progression on Enzalutamide (PMSABR Study)
- ClinicalTrials.gov ID
- NCT04742972
- Acronym / sponsor ID
- PST010
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The lack of well-defined oligometastasis, high disease burden in mCRPC and high sensitivity of PSMA-PET scan, PMSABR study was made with high ambition and the assumption on recruitment was found to be invalid.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Darren PoonUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 8 Feb 2021 (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.
In this study, the investigator aim to evaluate the role of PMSA-PET guided SABR on progression free survival (PFS) in patients with oligoprogressive mCRPC with Enzalutamide. The potential improvement in PFS with SABR while continuing the initial-responding Enzalutamide is potentially benefiting to patients in terms of overall disease control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SABR | Experimental | Radiation: SABR |
| SOC | Placebo comparator | Other: SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histological confirmation of prostate adenocarcinoma
- Evidence of stage IV disease (as defined by AJCC criteria) on previous bone, CT, and/or MRI scan
- Ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (ie, surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit
- ECOG performance score 0-2
- Age ≥ 18
Key exclusion criteria (12 listed)
- Patients with active cancer other than prostate cancer and non-melanoma skin cancer.
- Prior treatment with docetaxel, another chemotherapy agent or second generation hormonal therapy (e.g. abiraterone acetate or enzalutamide) for metastatic castration-resistant prostate cancer. Prior docetaxel, abiraterone acetate or enzalutamide for metastatic hormone-sensitive prostate cancer is allowed if ≥ 12 months elapsed from last dose of these treatments.
- PSA at inclusion >20 ng/ml
- Serum creatinine and total bilirubin > 3 times the upper limit of normal
- Liver Transaminases > 5-times the upper limit of normal
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 |
|---|---|---|
| SABRSABR is delivered to all sites of oligometastasis with continuation of Enzalutamide. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in SOC Arm. | Radiation | SABR |
| SOCThree options: 1. Continuation of Enzalutamide 2. Observation 3. Switch to next line treatment | Other | SOC |
Primary outcome
The 6-month progression-Free Survival rate
Time frame: up to 2 years
9 secondary outcomes
Progression-Free Survival
Time frame: 2 years
Time to progression
Time frame: 2 years
Overall survival
Time frame: 2 years
Local control rate of the SABR-treated oligometastasis at 6 months after SABR
Time frame: up to 2 years
Local control rate of the SABR-treated oligometastasis at 6 months after SABR based on the PERCIST criteria
Time frame: up to 2 years
QOL (EORTC QLQ-C30)
Time frame: 2 years
Time to next systemic treatment
Time frame: 2 years
The number of participants with treatment-related adverse event as assessed by CTCAE v4.0
Time frame: 2 years
The proportion of patients in both arms who have AR-V7 (CTCs)
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SABR and SOC in people with Prostate Cancer, run by Darren Poon.
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 16 inclusion and 12 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: withdrawn, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 6-month progression-Free Survival rate (time frame: up to 2 years). 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 9 Dec 2022.