Prostate AdenocarcinomaPhase 2NCT07251829
Neoadjuvant Embolization and Cytoreduction in Prostate Cancer
A Phase 2 study testing Prostatic Artery Embolization in people with Prostate Adenocarcinoma, run by Srinivas Raman.
Trial summary
The goal of this clinical trial is to find out whether prostate artery embolization (PAE) can help prevent or lessen urinary side effects caused by radiotherapy (RT) in people with prostate cancer, especially those who have larger prostates or urinary symptoms before treatment. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Prostatic Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Dec 2027
- Phase
- Phase 2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed prostate adenocarcinoma with planned RT to the prostate
- Baseline (pre-PAE) prostate volume ≥ 50 cc
- Baseline (pre-PAE) IPSS ≥ 15
- If planned or ongoing ADT and/or 5-alpha reductase inhibitor (5ARI), patient should be on therapy for at least 12 weeks, and meet prostate volume and pre-PAE IPSS criteria at the time of enrollment.
Who cannot join
- Baseline (pre-PAE) IPSS storage/voiding ratio ≥ 1
- Previous prostate treatment (TURP, Laser therapies, MISTs)
- Chronic urinary retention requiring use of indwelling urinary catheter.
- Neurogenic bladder or other neurological disorder that is impacting bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.).
- Active urinary tract infections or recurrent urinary tract infections (>2/year), prostatitis, or interstitial cystitis.
- Receipt of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND patient has not been on the same drug dosage for 6 months with a stable voiding pattern.
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- Hypersensitivity reactions to contrast material not manageable with prophylaxis.
- Glomerular filtration rates less than 40 mL/min (unless on dialysis).
- Bilateral internal iliac arterial occlusion.
About this study
Official title: Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity in Prostate Cancer
The goal of this clinical trial is to find out whether prostate artery embolization (PAE) can help prevent or lessen urinary side effects caused by radiotherapy (RT) in people with prostate cancer, especially those who have larger prostates or urinary symptoms before treatment.
The main questions this study aims to answer are:
Read more
- Does PAE before RT reduce the severity of urinary side effects from RT?
- Does PAE affect the rates of genitourinary (GU) or gastrointestinal (GI) side effects after RT?
Researchers will look at changes in urinary symptoms from the start of the study to 6 months after PAE. They will also record any GU or GI side effects related to RT.
Participants will receive prostate artery embolization before starting radiotherapy, and complete questionnaires and assessments about GU and GI functions before and after treatment.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Prostatic Artery Embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery EmbolizationProcedure or surgery
PAE is a minimally invasive procedure that involves embolizing the arteries supplying the prostate, leading to its shrinkage.
| Study group | Role | What they receive |
|---|---|---|
| PAE | Experimental | Neoadjuvant PAE before RT Receives: Procedure: Prostatic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LUTS symptoms measured by the IPSS at 6 months post-PAE
Measured: From enrollment to the 12 months after PAE
Secondary outcomes (10)
Rates of Grade ≥2 GU and GI RT toxicity as assessed by CTCAE v5.0
Measured: From enrollment to 12 months after PAE
Rates of PAE intraoperative and postoperative adverse events as assessed by Clavien-Dindo and CTCAE v5.0
Measured: From the start of PAE to 12 months after PAE
Prostatic Specific antigen (PSA) at 6 months post-PAE
Measured: From enrollment to 12 months after PAE
Change in prostate volume calculated by TRUS at 6 months post-PAE
Measured: From enrollment to 12 months after PAE
Change in peak urinary flow rate (Qmax, ml/s) at 6 months post-PAE
Measured: From enrollment to 6 months after PAE
Change in postvoid residual urine (PVR, ml) at 6 months post-PAE
Measured: From enrollment to 6 months after PAE
Change in bladder and rectum mean RT dose from pre-PAE to pre-RT simulation scan
Measured: From pre-PAE simulation scan to pre-RT simulation scan
Urinary quality of life assessed by IPSS QoL scores
Measured: From enrollment to 12 months after PAE
Rate of local re-intervention for LUTS
Measured: From enrollment to 6 months after PAE
Erectile dysfunction assessed by the International Index of Erectile Function (IIEF-5) questionnaire
Measured: From enrollment to 12 months after PAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startFeb 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Srinivas Raman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Srinivas Raman, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251829
- Sponsor's protocol ID
- NECTAR
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity in Prostate Cancer
- ClinicalTrials.gov ID
- NCT07251829
- Acronym / sponsor ID
- NECTAR
- Conditions
- Prostate Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Srinivas RamanUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Nov 2025 (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 find out whether prostate artery embolization (PAE) can help prevent or lessen urinary side effects caused by radiotherapy (RT) in people with prostate cancer, especially those who have larger prostates or urinary symptoms before treatment.
The main questions this study aims to answer are:
- Does PAE before RT reduce the severity of urinary side effects from RT?
- Does PAE affect the rates of genitourinary (GU) or gastrointestinal (GI) side effects after RT?
Researchers will look at changes in urinary symptoms from the start of the study to 6 months after PAE. They will also record any GU or GI side effects related to RT.
Participants will receive prostate artery embolization before starting radiotherapy, and complete questionnaires and assessments about GU and GI functions before and after treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAE | Experimental | Procedure: Prostatic Artery EmbolizationNeoadjuvant PAE before RT |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed prostate adenocarcinoma with planned RT to the prostate
- Baseline (pre-PAE) prostate volume ≥ 50 cc
- Baseline (pre-PAE) IPSS ≥ 15
- If planned or ongoing ADT and/or 5-alpha reductase inhibitor (5ARI), patient should be on therapy for at least 12 weeks, and meet prostate volume and pre-PAE IPSS criteria at the time of enrollment.
Key exclusion criteria (9 listed)
- Baseline (pre-PAE) IPSS storage/voiding ratio ≥ 1
- Previous prostate treatment (TURP, Laser therapies, MISTs)
- Chronic urinary retention requiring use of indwelling urinary catheter.
- Neurogenic bladder or other neurological disorder that is impacting bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.).
- Active urinary tract infections or recurrent urinary tract infections (>2/year), prostatitis, or interstitial cystitis.
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 |
|---|---|---|
| Prostatic Artery EmbolizationPAE is a minimally invasive procedure that involves embolizing the arteries supplying the prostate, leading to its shrinkage. | Procedure or surgery | PAE |
Primary outcome
Change in LUTS symptoms measured by the IPSS at 6 months post-PAE
Time frame: From enrollment to the 12 months after PAE
10 secondary outcomes
Rates of Grade ≥2 GU and GI RT toxicity as assessed by CTCAE v5.0
Time frame: From enrollment to 12 months after PAE
Rates of PAE intraoperative and postoperative adverse events as assessed by Clavien-Dindo and CTCAE v5.0
Time frame: From the start of PAE to 12 months after PAE
Prostatic Specific antigen (PSA) at 6 months post-PAE
Time frame: From enrollment to 12 months after PAE
Change in prostate volume calculated by TRUS at 6 months post-PAE
Time frame: From enrollment to 12 months after PAE
Change in peak urinary flow rate (Qmax, ml/s) at 6 months post-PAE
Time frame: From enrollment to 6 months after PAE
Change in postvoid residual urine (PVR, ml) at 6 months post-PAE
Time frame: From enrollment to 6 months after PAE
Change in bladder and rectum mean RT dose from pre-PAE to pre-RT simulation scan
Time frame: From pre-PAE simulation scan to pre-RT simulation scan
Urinary quality of life assessed by IPSS QoL scores
Time frame: From enrollment to 12 months after PAE
Rate of local re-intervention for LUTS
Time frame: From enrollment to 6 months after PAE
Erectile dysfunction assessed by the International Index of Erectile Function (IIEF-5) questionnaire
Time frame: From enrollment to 12 months after PAE
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 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostatic Artery Embolization in people with Prostate Adenocarcinoma, run by Srinivas Raman.
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 4 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: opening soon, as of the sponsor's last update on 26 Nov 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Change in LUTS symptoms measured by the IPSS at 6 months post-PAE (time frame: From enrollment to the 12 months after PAE). 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 26 Nov 2025.