ProstatePhase 2NCT03047135
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
A Phase 2 study testing Olaparib in people with Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 sites in United States.
Trial summary
Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate
- What is being tested?
- Olaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2017to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologic diagnosis of adenocarcinoma of the prostate
- Prior local therapy with prostatectomy required, with available tissue from prostatectomy specimen to send for genomic and transcriptomic testing.
- Prior salvage or adjuvant radiation therapy is allowed but not mandated. Radiation therapy must have been completed for at least 6 months.
- Absolute PSA ≥1 ng/ml. Prior undetectable PSA post-prostatectomy is not required.
- PSADT ≤6 months, based upon ≥3 consecutive measurements collected in the past 12 months, at least 4 weeks apart
- No radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks.
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- Serum testosterone ≥ 150 ng/dl
- Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 75 x 109/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) <2.5 x institutional upper limit of normal. Note: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded.
- Patients must have creatinine clearance estimated using the Cockcroft
- Gault equation of ≥51 mL/min:
- Estimated creatinine clearance = (140-age [years]) x weight (kg) serum creatinine (mg/dL) x 72
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Male participants and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination [see appendix F for acceptable methods], throughout the period of taking study treatment and for 3 months after last dose of study drug to prevent pregnancy in a partner.
- For enrichment stage of trial only (if necessary): Confirmation of a suspected/known deleterious mutation in a gene of interest (ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or other DNA repair genes) via CLIA certified testing.
Who cannot join
- Prior ADT in the past 6 months. Prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (>150 ng/dl). The total duration of prior ADT should not exceed 24 months.
- Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) in the past 6 months. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months.
- Prior treatment with intravenous chemotherapy.
- Involvement in the planning and/or conduct of the study
- Participation in another clinical study with an investigational product during the last 1 month.
- Any previous treatment with PARP inhibitor, including olaparib
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- Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
- Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- Concomitant use of known strong CYP3A inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.
- Myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Known hypersensitivity to olaparib or any of the excipients of the product.
- Known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
- Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to inclusion criteria no.10)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21231
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Phase II Study of Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response.
Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.
Read the detailed description
The proposed study is an open-label single-arm phase II trial.
Eligible patients are those with non-metastatic biochemically-recurrent prostate cancer and a PSADT of ≤6 months and a minimum PSA of 1.0.
After enrollment, patients will be treated with olaparib at the established dose of 300mg tablets by mouth twice daily. Patients will be followed monthly with clinic visits, safety labs (including CBC w/diff, Comp), PSA, and toxicity assessments. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA doubling from study entry (confirmed with another measurement at least 4 weeks later), development of radiographic metastatic disease, or toxicity requiring drug cessation. CT scans and NM bone scans will be performed every 6 months for patients remaining on olaparib treatment.
This study will enroll up to 50 subjects. The study design will employ a stepwise adaptive statistical plan, derived in part from Biankin et al, Nature 2015 Oct 15;526(7573):361-70. The design is adapted from a multi-stage design, with interim stopping rules to determine futility or need for enrichment of the study population.
The study will initiate with a two-stage design in an unselected population. The assumptions for the trial of the unselected population are: null hypothesis of 0.1 PSA response rate and alternative hypothesis of 0.3 for the unselected population. The first stage is 20 subjects. If ≤2 subjects responds in the first stage, then unselected population study is halted for futility and an assessment of DNA mutations present in the initial cohort will be undertaken. If less than 3 subjects with a known/suspected deleterious mutation in the following genes (ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or other DNA repair genes) have been accrued in the first stage, then the trial will proceed with enrichment. If 3 or more subjects with known/suspected deleterious mutation in the genes of interest have been accrued, then the trial will proceed with enrichment, as long as the response rate in that subset of subjects is ≥20%. In the case that 3 or more subjects have been accrued, yet the response rate in that subset is <20%, then the trial is halted for futility.
However, if ≥3 subjects among the first 20 respond, then additional 10 unselected subjects are accrued. If ≥6 subjects respond out of 30 in the unselected population after the second stage, then the null hypothesis is rejected in the unselected population and broad efficacy will be concluded.
The trial proceeds to complete accrual of 50 subjects in order to better estimate PSA response rate and strengthen data for correlative studies. If <6 respond, then the null hypothesis is not rejected. Again, if less than 3 subjects with a known/suspected deleterious mutation in the following genes (ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or other DNA repair genes) have been accrued in the first and second stage combined, then the trial will proceed with enrichment. If 3 or more subjects with those mutations have been accrued, then enrichment will again proceed as long as the response rate in that subject of subjects is ≥20%.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
| Study group | Role | What they receive |
|---|---|---|
| Olaparib 300 mg BID | Experimental | Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. Receives: Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA50 Response Rate to Olaparib for Patients With High-risk Biochemically-recurrent Prostate Cancer
Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value, confirmed with a second measurement at least 4 weeks apart.
Measured: 6 years 2 months
Secondary outcomes (4)
Treatment-related Adverse Events as Assessed by CTCAE v4.0
Number of participants with treatment related adverse events
Measured: Baseline to End of Treatment
PSA Progression-free Survival
Defined as a time from initiation on olaparib therapy until PSA increase of 25%, confirmed with another measurement at least 4 weeks later.
Measured: 7 years
PSA Doubling From Baseline
Measured: 7 years
Duration of Undetectable PSA
Number of patients on study with olaparib who achieves a PSA < 0.1, which is confirmed with a repeat measurement at least 12 weeks later.
Measured: 7 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 2017 (estimated)
- Study start1 Mar 2017
- Primary completion24 May 2023
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Catherine H Marshall, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047135
- Sponsor's protocol ID
- J16163
- Other IDs
- IRB00114635
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2017
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marshall CH, Teply BA, Lu J, Oliveira L, Wang H, Mao SS, Kelly WK, Paller CJ, Markowski MC, Denmeade SR, King S, Sullivan R, Davicioni E, Proudfoot JA, Eisenberger MA, Carducci MA, Lotan TL, Antonarakis ES. Olaparib Without Androgen Deprivation for High-Risk Biochemically Recurrent Prostate Cancer Following Prostatectomy: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Oct 1;10(10):1400-1408. doi: 10.1001/jamaoncol.2024.3074.
PubMed 39172479
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
- ClinicalTrials.gov ID
- NCT03047135
- Acronym / sponsor ID
- J16163
- Conditions
- Prostate
- Keywords
- high-risk biochemically-recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response.
Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.
Detailed description
The proposed study is an open-label single-arm phase II trial.
Eligible patients are those with non-metastatic biochemically-recurrent prostate cancer and a PSADT of ≤6 months and a minimum PSA of 1.0.
After enrollment, patients will be treated with olaparib at the established dose of 300mg tablets by mouth twice daily. Patients will be followed monthly with clinic visits, safety labs (including CBC w/diff, Comp), PSA, and toxicity assessments. Treatment [with a minimum drug exposure of 12 weeks] will be continued until PSA doubling from study entry (confirmed with another measurement at least 4 weeks later), development of radiographic metastatic disease, or toxicity requiring drug cessation. CT scans and NM bone scans will be performed every 6 months for patients remaining on olaparib treatment.
This study will enroll up to 50 subjects. The study design will employ a stepwise adaptive statistical plan, derived in part from Biankin et al, Nature 2015 Oct 15;526(7573):361-70. The design is adapted from a multi-stage design, with interim stopping rules to determine futility or need for enrichment of the study population.
The study will initiate with a two-stage design in an unselected population. The assumptions for the trial of the unselected population are: null hypothesis of 0.1 PSA response rate and alternative hypothesis of 0.3 for the unselected population. The first stage is 20 subjects. If ≤2 subjects responds in the first stage, then unselected population study is halted for futility and an assessment of DNA mutations present in the initial cohort will be undertaken. If less than 3 subjects with a known/suspected deleterious mutation in the following genes (ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or other DNA repair genes) have been accrued in the first stage, then the trial will proceed with enrichment. If 3 or more subjects with known/suspected deleterious mutation in the genes of interest have been accrued, then the trial will proceed with enrichment, as long as the response rate in that subset of subjects is ≥20%. In the case that 3 or more subjects have been accrued, yet the response rate in that subset is <20%, then the trial is halted for futility.
However, if ≥3 subjects among the first 20 respond, then additional 10 unselected subjects are accrued. If ≥6 subjects respond out of 30 in the unselected population after the second stage, then the null hypothesis is rejected in the unselected population and broad efficacy will be concluded.
The trial proceeds to complete accrual of 50 subjects in order to better estimate PSA response rate and strengthen data for correlative studies. If <6 respond, then the null hypothesis is not rejected. Again, if less than 3 subjects with a known/suspected deleterious mutation in the following genes (ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, or other DNA repair genes) have been accrued in the first and second stage combined, then the trial will proceed with enrichment. If 3 or more subjects with those mutations have been accrued, then enrichment will again proceed as long as the response rate in that subject of subjects is ≥20%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olaparib 300 mg BID | Experimental | Drug: OlaparibPatients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologic diagnosis of adenocarcinoma of the prostate
- Prior local therapy with prostatectomy required, with available tissue from prostatectomy specimen to send for genomic and transcriptomic testing.
- Prior salvage or adjuvant radiation therapy is allowed but not mandated. Radiation therapy must have been completed for at least 6 months.
- Absolute PSA ≥1 ng/ml. Prior undetectable PSA post-prostatectomy is not required.
- PSADT ≤6 months, based upon ≥3 consecutive measurements collected in the past 12 months, at least 4 weeks apart
Key exclusion criteria (17 listed)
- Prior ADT in the past 6 months. Prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (>150 ng/dl). The total duration of prior ADT should not exceed 24 months.
- Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) in the past 6 months. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months.
- Prior treatment with intravenous chemotherapy.
- Involvement in the planning and/or conduct of the study
- Participation in another clinical study with an investigational product during the last 1 month.
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 |
|---|---|---|
| OlaparibOlaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study. | Drug | Olaparib 300 mg BID |
Primary outcome
PSA50 Response Rate to Olaparib for Patients With High-risk Biochemically-recurrent Prostate Cancer
Time frame: 6 years 2 months
Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value, confirmed with a second measurement at least 4 weeks apart.
4 secondary outcomes
Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline to End of Treatment
PSA Progression-free Survival
Time frame: 7 years
PSA Doubling From Baseline
Time frame: 7 years
Duration of Undetectable PSA
Time frame: 7 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39172479Marshall CH, Teply BA, Lu J, Oliveira L, Wang H, Mao SS, Kelly WK, Paller CJ, Markowski MC, Denmeade SR, King S, Sullivan R, Davicioni E, Proudfoot JA, Eisenberger MA, Carducci MA, Lotan TL, Antonarakis ES. Olaparib Without Androgen Deprivation for High-Risk Biochemically Recurrent Prostate Cancer Following Prostatectomy: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Oct 1;10(10):1400-1408. doi: 10.1001/jamaoncol.2024.3074.
- 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.
Catherine H Marshall, MD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib in people with Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 4 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 19 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PSA50 Response Rate to Olaparib for Patients With High-risk Biochemically-recurrent Prostate Cancer (time frame: 6 years 2 months). 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 NCT03047135, 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 30 Oct 2026.