Prostate CancerPhase 1/2NCT02805894
NBTXR3 Nanoparticles and EBRT or EBRT With Brachytherapy in the Treatment of Prostate Adenocarcinoma
A Phase 1/2 study testing NBTXR3 activated by IMRT only and NBTXR3 activated by Brachytherapy & IMRT in people with Prostate Cancer, run by Nanobiotix at 2 sites in United States.
Trial summary
This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will receive only EBRT and the other group will receive a Brachytherapy boost and EBRT. 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?
- NBTXR3 activated by IMRT only and NBTXR3 activated by Brachytherapy & IMRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2017to 19 Mar 2020
- Phase
- Phase 1/2
- 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
- Age ≥ 18
- Histologically confirmed adenocarcinoma of the prostate gland by needle core samples with assigned Gleason score
- Subjects ADT naive or subjects who are already on ADT treatment and scheduled to receive radiation therapy for their adenocarcinoma of prostate are eligible. An 8-week course of ADT is required to be completed prior to NBTXR3 administration and initiation of radiation therapy.
- Pelvic and para-aortic lymph nodes must be negative on CT-scan or MRI of the abdomen and pelvis performed within 12 weeks prior to enrollment into the study
- Prostate adenocarcinoma with High Risk (HR) and Unfavorable Intermediate Risk (UIR) for recurrence classification as determined by one of the following combinations:
- High risk (HR): subjects with one or more of the following risk factors:
Show all 31Show fewer
- Clinical stage: T3/T4
- Gleason score (GS): 8-10
- PSA > 20
- N0
- Unfavorable Intermediate Risk (UIR): subjects with no HR features but with one or more of the following adverse risk factors:
- At least 2 of the following 3 factors: Gleason score(GS) 3+4=7 and/or PSA 10-20 and/or T2b/c
- Gleason score (GS) 4+3=7
- Greater than 50% of biopsy cores positive and at least one other risk factor:
- Gleason score (GS) 7 and/or PSA 10-20 and/or T2b/c
- No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if bone CT or MRI of hot spots are negative for metastasis
- Baseline serum PSA value performed with an FDA-approved assay within 120 days prior to registration. Study entry PSA should not be obtained within 10-day period following prostate biopsy or following initiation of hormonal therapy
- ECOG performance status must be 0 or 1
- Adequate function of bone marrow:
- Hemoglobin > 100 g/L
- Absolute Neutrophils > 1.5 x 109/L
- Platelets > 100 x 109/L,
- Adequate function of kidney:
- Serum creatinine < 1.5 x ULN
- Adequate function of liver:
- AST ≤ 3.0 x ULN
- ALT ≤ 3.0 x ULN
- Total bilirubin ≤ 1.5 x ULN
- Non-Childbearing Potential: Male subjects and their partners must meet one of the following criteria to be considered of non-childbearing potential:
- Males have undergone sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate, or
- Heterosexually active males and their partners of childbearing potential must agree or use at least 2 forms of highly effective methods of contraception, including at least 1 barrier method. Highly effective methods of contraception are those that, alone or in combination, result in a failure rate of <1% per year when used consistently and correctly (i.e., perfect use). Contraception must include male condom or female condom used with a spermicide (i.e., foam, gel, film, cream, suppository) as well as established use of oral, injected or implanted hormonal methods of contraception, correctly placed intrauterine device or intrauterine system.
Who cannot join
- Written Informed Consent not obtained, signed and dated
- History of colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases or proximal urethral stricture requiring dilatation
- Prostate size volume ≥90 cc
- Brachytherapy with EBRT in subjects whose prostate volume is >60cc
- Severe, active co-morbidity, defined as follows:
- Inflammatory bowel disease, active rectal diverticulitis, Crohn's disease affecting the rectum, anal stenosis or ulcerative colitis. (Nonactive diverticulitis and Crohn's disease not affecting the rectum are allowed)
Show all 21Show fewer
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC (Centers for Disease Control) definition
- Prior invasive malignancy, except non-melanoma skin cancer, carcinoma in-situ of the bladder or head and neck region, unless disease free for a minimum of 2 years
- Subjects with congenital long QT syndrome or subjects taking Class IA, Class III or Class IC anti-arrhythmic medications will require a cardiologist's evaluation prior to eligibility assessment. subjects with cardiovascular diseases can be included as long as the benefits of androgen deprivation therapy outweigh the potential risk of cardiovascular events
- Uncontrolled lung disease
- Subjects with any evidence of distant metastases
- subjects with any contraindication to pelvic radiotherapy including, but not limited to, previous pelvic radiotherapy or brachytherapy
- Presence of bilateral hip replacement prostheses
- Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
- Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician
- Complete initial work up earlier than 12 weeks prior to subject registration
- Subjects unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Subjects participating in another clinical investigation at the time of signature of the informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute/Brigham and Women's Hospital
Boston, Massachusetts, 02115
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase I-II Dose-escalation Study of NBTXR3 Activated by EBRT or EBRT With Brachytherapy in Patients With Newly Diagnosed Unfavorable Intermediate or High Risk Prostate Adenocarcinoma Treated With Androgen Deprivation
This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will receive only EBRT and the other group will receive a Brachytherapy boost and EBRT. Both groups will receive treatment with androgen deprivation. There will be 2 consecutive steps, a dose escalation and a subsequent dose expansion part.
Read the detailed description
This is a Phase 1/2 prospective, open-label, two cohorts, non-randomized trial consisting of two consecutive steps, a dose escalation and a subsequent dose expansion part.
PART 1 DOSE ESCALATION: subjects with newly diagnosed Unfavorable Intermediate
Risk (UIR) or High Risk (HR) prostate adenocarcinoma, will participate in a dose escalation of NBTXR3 activated by two different radiation schedules. NBTXR3 will be administered by intra-prostate injection and then activated 10 days later either by:
- EBRT delivered as 45 Gy in 25 fractions of 1.8 Gy each; to the prostate and seminal vesicles, followed by 34.2 Gy in 19 fractions to the prostate and proximal seminal vesicles, over 9-10 weeks, utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT A) or,
- Brachytherapy Boost and EBRT delivered as a single fraction of 15 Gy in one day to the prostate by High Dose Rate Brachytherapy followed by EBRT (initiated within 2-4 weeks after completion of Brachytherapy), delivered as 45 Gy in 25 fractions of 1.8 Gy to the prostate and seminal vesicles utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT B)
PART 2 DOSE EXPANSION: Two parallel cohorts of subjects, A and B, 20 subjects per cohort, will be treated at either the RD1 (Recommended Dose of NBTXR3 given as intraprostate injection and activated by EBRT) or RD2 (Recommended Dose of NBTXR3 given as intra-prostate injection and activated by Brachytherapy Boost and EBRT), as determined in the Phase I dose escalation of the trial.
All subjects will receive androgen deprivation therapy (ADT) LHRH / GnRH agonist beginning 8 weeks before the NBTXR3 administration and for 24 months in subjects with (HR) prostate adenocarcinoma. The duration of ADT in subjects with (UIR) disease will be of 6 months.
Subjects will receive a single intra-prostate injection of NBTXR3 which will be delivered to the prostate via transperineal injection under TRUS guidance injection. NBTXR3 injection will be performed on Day 1 and will be assessed for safety, intra-prostate availability and presence of NBTXR3 in the peripheral circulation.
COHORT A: External beam radiation therapy will be delivered to the prostate starting within 9 days after the NBTXR3 injection (Day 10). Total dose of 79.2 Gy, delivered as 25 fractions of 1.8 Gy to the prostate and seminal vesicles (45 Gy), followed by 34.2 Gy in 19 fractions to the prostate and proximal seminal vesicles, delivered over 9-10 weeks, utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers COHORT B: HDR Brachytherapy implantation will be performed within 9 days after NBTXR3 injection (Day 10). Brachytherapy Boost delivered as a single fraction of 15 Gy in one day to the prostate by High Dose Rate Brachytherapy followed by EBRT (initiated within 2-4 weeks after completion of Brachytherapy) delivered as 45 Gy in 25 fractions of 1.8 Gy to the prostate and seminal vesicles utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers.
Subjects will be followed for safety assessment until the end of the study. Before the onset of study treatment, subjects must have a histologic diagnosis of either Unfavorable Intermediate Risk (UIR) or High Risk (HR) prostate adenocarcinoma.
- Conditions
- Prostate Cancer
- Being tested
- NBTXR3 activated by IMRT only, NBTXR3 activated by Brachytherapy & IMRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBTXR3 activated by IMRT onlyDrug
Also called Hafnium Oxide nanoparticles
Single local administration of NBTXR3 by injection into the prostate gland prior to the IMRT treatment
NBTXR3 activated by Brachytherapy & IMRTDrug
Also called Hafnium Oxide nanoparticles
Single local administration of NBTXR3 by injection into the prostate gland prior to the Brachytherapy \& IMRT treatment
| Study group | Role | What they receive |
|---|---|---|
| NBTXR3 activated by IMRT only | Experimental | Part I Dose Escalation
NBTXR3 will be administered by intra-prostate injection and then activated 10 days later by:
- EBRT delivered as 45 Gy in 25 fractions of 1.8 Gy each; to the prostate and seminal vesicles, followed by 34.2 Gy in 19 fractions to the prostate and proximal seminal vesicles , over 9-10 weeks, utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT A) Receives: Drug: NBTXR3 activated by IMRT only |
| NBTXR3 activated by Brachytherapy & IMRT | Experimental | Part I Dose Escalation
NBTXR3 will be administered by intra-prostate injection and then activated 10 days later by:
- Brachytherapy Boost and EBRT delivered as a single fraction of 15 Gy in one day to the prostate by High Dose Rate Brachytherapy followed by EBRT (initiated within 2-4 weeks after completion of Brachytherapy), delivered as 45 Gy in 25 fractions of 1.8 Gy to the prostate and seminal vesicles utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT B) Receives: Drug: NBTXR3 activated by Brachytherapy & IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose and early Dose Limiting Toxicities (DLT) of NBTXR3
Measured: 24 months
Recommended Dose(s) of NBTXR3
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start15 Nov 2017
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Why it stopped: Prostate cancer treatment has greatly changed since the initiation of this trial and therefore we have stopped this trial to allow for further evaluation of the treatment landscape
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanobiotix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Dicker, MD, Principal investigator, Thomas Jefferson University Hospital Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805894
- Sponsor's protocol ID
- NBTXR3-104
- Status last verified
- May 2021
- First submitted
- 10 Jun 2016
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Dose-escalation Study of NBTXR3 Activated by EBRT or EBRT With Brachytherapy in Patients With Newly Diagnosed Unfavorable Intermediate or High Risk Prostate Adenocarcinoma Treated With Androgen Deprivation
- ClinicalTrials.gov ID
- NCT02805894
- Acronym / sponsor ID
- NBTXR3-104
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prostate cancer treatment has greatly changed since the initiation of this trial and therefore we have stopped this trial to allow for further evaluation of the treatment landscape
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NanobiotixIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will receive only EBRT and the other group will receive a Brachytherapy boost and EBRT. Both groups will receive treatment with androgen deprivation. There will be 2 consecutive steps, a dose escalation and a subsequent dose expansion part.
Detailed description
This is a Phase 1/2 prospective, open-label, two cohorts, non-randomized trial consisting of two consecutive steps, a dose escalation and a subsequent dose expansion part.
PART 1 DOSE ESCALATION: subjects with newly diagnosed Unfavorable Intermediate
Risk (UIR) or High Risk (HR) prostate adenocarcinoma, will participate in a dose escalation of NBTXR3 activated by two different radiation schedules. NBTXR3 will be administered by intra-prostate injection and then activated 10 days later either by:
- EBRT delivered as 45 Gy in 25 fractions of 1.8 Gy each; to the prostate and seminal vesicles, followed by 34.2 Gy in 19 fractions to the prostate and proximal seminal vesicles, over 9-10 weeks, utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT A) or,
- Brachytherapy Boost and EBRT delivered as a single fraction of 15 Gy in one day to the prostate by High Dose Rate Brachytherapy followed by EBRT (initiated within 2-4 weeks after completion of Brachytherapy), delivered as 45 Gy in 25 fractions of 1.8 Gy to the prostate and seminal vesicles utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT B)
PART 2 DOSE EXPANSION: Two parallel cohorts of subjects, A and B, 20 subjects per cohort, will be treated at either the RD1 (Recommended Dose of NBTXR3 given as intraprostate injection and activated by EBRT) or RD2 (Recommended Dose of NBTXR3 given as intra-prostate injection and activated by Brachytherapy Boost and EBRT), as determined in the Phase I dose escalation of the trial.
All subjects will receive androgen deprivation therapy (ADT) LHRH / GnRH agonist beginning 8 weeks before the NBTXR3 administration and for 24 months in subjects with (HR) prostate adenocarcinoma. The duration of ADT in subjects with (UIR) disease will be of 6 months.
Subjects will receive a single intra-prostate injection of NBTXR3 which will be delivered to the prostate via transperineal injection under TRUS guidance injection. NBTXR3 injection will be performed on Day 1 and will be assessed for safety, intra-prostate availability and presence of NBTXR3 in the peripheral circulation.
COHORT A: External beam radiation therapy will be delivered to the prostate starting within 9 days after the NBTXR3 injection (Day 10). Total dose of 79.2 Gy, delivered as 25 fractions of 1.8 Gy to the prostate and seminal vesicles (45 Gy), followed by 34.2 Gy in 19 fractions to the prostate and proximal seminal vesicles, delivered over 9-10 weeks, utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers COHORT B: HDR Brachytherapy implantation will be performed within 9 days after NBTXR3 injection (Day 10). Brachytherapy Boost delivered as a single fraction of 15 Gy in one day to the prostate by High Dose Rate Brachytherapy followed by EBRT (initiated within 2-4 weeks after completion of Brachytherapy) delivered as 45 Gy in 25 fractions of 1.8 Gy to the prostate and seminal vesicles utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers.
Subjects will be followed for safety assessment until the end of the study. Before the onset of study treatment, subjects must have a histologic diagnosis of either Unfavorable Intermediate Risk (UIR) or High Risk (HR) prostate adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBTXR3 activated by IMRT only | Experimental | Drug: NBTXR3 activated by IMRT onlyPart I Dose Escalation NBTXR3 will be administered by intra-prostate injection and then activated 10 days later by: - EBRT delivered as 45 Gy in 25 fractions of 1.8 Gy each; to the prostate and seminal vesicles, followed by 34.2 Gy in 19 fractions to the prostate and proximal seminal vesicles , over 9-10 weeks, utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT A) |
| NBTXR3 activated by Brachytherapy & IMRT | Experimental | Drug: NBTXR3 activated by Brachytherapy & IMRTPart I Dose Escalation NBTXR3 will be administered by intra-prostate injection and then activated 10 days later by: - Brachytherapy Boost and EBRT delivered as a single fraction of 15 Gy in one day to the prostate by High Dose Rate Brachytherapy followed by EBRT (initiated within 2-4 weeks after completion of Brachytherapy), delivered as 45 Gy in 25 fractions of 1.8 Gy to the prostate and seminal vesicles utilizing intensity modulated radiotherapy (IMRT) with daily image guidance aligned to implanted fiducial markers (COHORT B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Age ≥ 18
- Histologically confirmed adenocarcinoma of the prostate gland by needle core samples with assigned Gleason score
- Subjects ADT naive or subjects who are already on ADT treatment and scheduled to receive radiation therapy for their adenocarcinoma of prostate are eligible. An 8-week course of ADT is required to be completed prior to NBTXR3 administration and initiation of radiation therapy.
- Pelvic and para-aortic lymph nodes must be negative on CT-scan or MRI of the abdomen and pelvis performed within 12 weeks prior to enrollment into the study
- Prostate adenocarcinoma with High Risk (HR) and Unfavorable Intermediate Risk (UIR) for recurrence classification as determined by one of the following combinations:
Key exclusion criteria (21 listed)
- Written Informed Consent not obtained, signed and dated
- History of colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases or proximal urethral stricture requiring dilatation
- Prostate size volume ≥90 cc
- Brachytherapy with EBRT in subjects whose prostate volume is >60cc
- Severe, active co-morbidity, defined as follows:
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 |
|---|---|---|
| NBTXR3 activated by IMRT onlyAlso: Hafnium Oxide nanoparticlesSingle local administration of NBTXR3 by injection into the prostate gland prior to the IMRT treatment | Drug | NBTXR3 activated by IMRT only |
| NBTXR3 activated by Brachytherapy & IMRTAlso: Hafnium Oxide nanoparticlesSingle local administration of NBTXR3 by injection into the prostate gland prior to the Brachytherapy \& IMRT treatment | Drug | NBTXR3 activated by Brachytherapy & IMRT |
Primary outcome
Maximum Tolerated Dose and early Dose Limiting Toxicities (DLT) of NBTXR3
Time frame: 24 months
Recommended Dose(s) of NBTXR3
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Prostate cancer treatment has greatly changed since the initiation of this trial and therefore we have stopped this trial to allow for further evaluation of the treatment landscape). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
Active, not recruitingPhase 1
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer, Adenocarcinoma of the Prostate
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruiting
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
Prostate, Cancer
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.
Adam Dicker, MD principal investigator
Thomas Jefferson University Hospital Philadelphia, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NBTXR3 activated by IMRT only and NBTXR3 activated by Brachytherapy & IMRT in people with Prostate Cancer, run by Nanobiotix at 2 sites in United States.
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 31 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: Prostate cancer treatment has greatly changed since the initiation of this trial and therefore we have stopped this trial to allow for further evaluation of the treatment landscape). Results are not available in the source record.
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?
Maximum Tolerated Dose and early Dose Limiting Toxicities (DLT) of NBTXR3 (time frame: 24 months). The study lists 2 primary outcomes in all. 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 10 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.