Prostate CancerPhase 2BURSTNCT07867158
Study of Boswellia for Urinary Toxicity in Prostate Cancer Radiotherapy
A Phase 2 study testing Boswellia serrata extract in people with Prostate Cancer, run by Brigham and Women's Hospital.
Trial summary
The goal of this clinical trial is to determine whether Boswellia serrata extract is effective at reducing urinary symptoms in patients undergoing radiation for prostate cancer. The main question it aims to answer is whether patients taking Boswellia report significantly improved urinary symptoms at the 1-week… 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?
- Boswellia serrata extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically-proven prostate cancer undergoing fractionated radiation for prostate cancer.
- Patients must be developing worsening urinary symptoms from radiation as evaluated by treating physician.
- Fractionated radiation must be targeted at either the intact prostate or the prostate fossa (surgical bed) in cases of prior prostatectomy.
- Radiation fields may also include treatment of the pelvic lymph node basins and/or more distant targets including but not limited to nearby bone metastases and retroperitoneal lymph nodes.
- Brachytherapy boost prior or subsequent to external beam radiation course is allowed.
- Patients must have at least 1 week or more of scheduled radiation treatments remaining prior to enrollment in order to allow for data collection at the following week's routine on-treatment visit.
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- Participants with a prior or concurrent malignancy or prior radiation are eligible for this trial.
- Age ≥18 years.
- Patients must be able to read and speak English or else be able to use interpreter services to communicate with providers and complete questionnaires.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who are unable or unwilling to return for future visits to assess toxicity changes.
- Participants lacking the functional capacity required to report and describe their symptoms.
- Participants who are unable to swallow pills or have known allergy/adverse reaction to Boswellia.
- Participants with known moderate to severe liver disease.
- Participants taking medications which may interfere with the administration of Boswellia per the treating physician.
- Participants previously started on another agent for acute urinary toxicity (e.g. tamsulosin, ibuprofen, etc.) during the radiation course will be excluded. Additionally, Boswellia will be the only new agent started for urinary toxicity at the time of enrollment for the initial 1 week period. Future initiation of additional interventions and medications after the first week will be allowed.
- Participants for whom there is physician concern for interactions with patients' existing medications.
- Participants taking any of the following medications: clarithromycin, ketoconazole, ritonavir, itraconazole, nefazodone, indinavir, and saquinavir, carbamazepine, phenytoin, phenobarbital, rifampicin, St. John's wort
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2 Study of Boswellia for Treating Urinary Toxicity in Prostate Cancer Radiotherapy
The goal of this clinical trial is to determine whether Boswellia serrata extract is effective at reducing urinary symptoms in patients undergoing radiation for prostate cancer. The main question it aims to answer is whether patients taking Boswellia report significantly improved urinary symptoms at the 1-week timepoint after taking a minimum of two (2) days of Boswellia treatment.
Participants will follow a treatment plan of 1500 mg of oral Boswellia, taken three times per day, and will report their symptoms and side effects using a specialized questionnaire.
- Conditions
- Prostate Cancer
- Being tested
- Boswellia serrata extract
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boswellia serrata extractDrug
Also called Indian Frankincense
Boswellia 1500 mg three times per day, taken orally for up to 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Boswellia | Experimental | Boswellia 1500 mg three times per day, taken orally for up to 10 weeks Receives: Drug: Boswellia serrata extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in genitourinary (GU) toxicity from prostate radiation after the initiation of Boswellia as assessed by changes in patient reported outcomes
The primary outcome endpoint will be the percentage of participants who experience improvement in urinary toxicity with Boswellia at the 1-week timepoint after a minimum of 2 days of treatment as determined by participants who mark "Improved" in response to the questionnaire item: "How have your urinary symptoms changed since starting Boswellia?" at the first weekly assessment.
Measured: 1 week after initiation of oral Boswellia treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Peng, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867158
- Sponsor's protocol ID
- 547387
- Acronym
- BURST
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547852/
PubMed 31643176Alluri VK, Dodda S, Kilari EK, Golakoti T, Sengupta K. Toxicological Assessment of a Standardized Boswellia serrata Gum Resin Extract. Int J Toxicol. 2019 Sep/Oct;38(5):423-435. doi: 10.1177/1091581819858069. Epub 2019 Jun 24.
PubMed 31234670Shang Y, Cui D, Yi S. Opening tight junctions may be key to opening the blood-prostate barrier. Med Sci Monit. 2014 Dec 2;20:2504-7. doi: 10.12659/MSM.890902.
PubMed 25448323Reising K, Meins J, Bastian B, Eckert G, Mueller WE, Schubert-Zsilavecz M, Abdel-Tawab M. Determination of boswellic acids in brain and plasma by high-performance liquid chromatography/tandem mass spectrometry. Anal Chem. 2005 Oct 15;77(20):6640-5. doi: 10.1021/ac0506478.
PubMed 16223251Kulkarni PD, Damle ND, Hingorani L, Bhaskar VH, Ghante MR, Patil A, Gurjar M, Gota V. Pharmacokinetics of solid lipid Boswellia serrata particles in healthy subjects. Drug Metab Pers Ther. 2021 Apr 5;36(3):215-221. doi: 10.1515/dmpt-2020-0176.
PubMed 34412175Peng C, Yang Y, Wang Y, Gong B, Sun X, Yang X. From bench to bedside, boswellic acids in anti-inflammatory therapy - mechanistic insights, bioavailability challenges, and optimization approaches. Front Pharmacol. 2025 Nov 18;16:1692443. doi: 10.3389/fphar.2025.1692443. eCollection 2025.
PubMed 41341032Presicce F, Barrese F, Cantiani A, Filianoti A, Tuzzolo D, Di Palma P, Lauretti S, Brunori S, Martini M. Boswellia resin extract and propolis derived polyphenols in patients with type III chronic prostatitis/chronic pelvic pain syndrome: An Italian prospective multicenter study. Asian J Urol. 2022 Apr;9(2):139-145. doi: 10.1016/j.ajur.2021.09.002. Epub 2021 Sep 11.
PubMed 35509480Schmidt C, Loos C, Jin L, Schmiech M, Schmidt CQ, Gaafary ME, Syrovets T, Simmet T. Acetyl-lupeolic acid inhibits Akt signaling and induces apoptosis in chemoresistant prostate cancer cells in vitro and in vivo. Oncotarget. 2017 Jul 8;8(33):55147-55161. doi: 10.18632/oncotarget.19101. eCollection 2017 Aug 15.
PubMed 28903409Pang X, Yi Z, Zhang X, Sung B, Qu W, Lian X, Aggarwal BB, Liu M. Acetyl-11-keto-beta-boswellic acid inhibits prostate tumor growth by suppressing vascular endothelial growth factor receptor 2-mediated angiogenesis. Cancer Res. 2009 Jul 15;69(14):5893-900. doi: 10.1158/0008-5472.CAN-09-0755. Epub 2009 Jun 30.
PubMed 19567671Lu M, Xia L, Hua H, Jing Y. Acetyl-keto-beta-boswellic acid induces apoptosis through a death receptor 5-mediated pathway in prostate cancer cells. Cancer Res. 2008 Feb 15;68(4):1180-6. doi: 10.1158/0008-5472.CAN-07-2978.
PubMed 18281494Coleman CN, Kelly L, Riese Daly N, Beard C, Kaplan I, Lamb C, Propert K, Manola J. Phase III study of ibuprofen versus placebo for radiation-induced genitourinary side effects. Int J Radiat Oncol Biol Phys. 2002 Sep 1;54(1):191-4. doi: 10.1016/s0360-3016(02)02907-3.
PubMed 12182991Elshaikh MA, Ulchaker JC, Reddy CA, Angermeier KW, Klein EA, Chehade N, Altman A, Ciezki JP. Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):164-9. doi: 10.1016/j.ijrobp.2004.09.036.
PubMed 15850917Prosnitz RG, Schneider L, Manola J, Rocha S, Loffredo M, Lopes L, D'Amico AV. Tamsulosin palliates radiation-induced urethritis in patients with prostate cancer: results of a pilot study. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):563-6. doi: 10.1016/s0360-3016(99)00246-1.
PubMed 10524406Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14.
PubMed 27626365Kirste S, Treier M, Wehrle SJ, Becker G, Abdel-Tawab M, Gerbeth K, Hug MJ, Lubrich B, Grosu AL, Momm F. Boswellia serrata acts on cerebral edema in patients irradiated for brain tumors: a prospective, randomized, placebo-controlled, double-blind pilot trial. Cancer. 2011 Aug 15;117(16):3788-95. doi: 10.1002/cncr.25945. Epub 2011 Feb 1.
PubMed 21287538
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Boswellia for Treating Urinary Toxicity in Prostate Cancer Radiotherapy
- ClinicalTrials.gov ID
- NCT07867158
- Acronym / sponsor ID
- BURST / 547387
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Oct 2026 (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 determine whether Boswellia serrata extract is effective at reducing urinary symptoms in patients undergoing radiation for prostate cancer. The main question it aims to answer is whether patients taking Boswellia report significantly improved urinary symptoms at the 1-week timepoint after taking a minimum of two (2) days of Boswellia treatment.
Participants will follow a treatment plan of 1500 mg of oral Boswellia, taken three times per day, and will report their symptoms and side effects using a specialized questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boswellia | Experimental | Drug: Boswellia serrata extractBoswellia 1500 mg three times per day, taken orally for up to 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with pathologically-proven prostate cancer undergoing fractionated radiation for prostate cancer.
- Patients must be developing worsening urinary symptoms from radiation as evaluated by treating physician.
- Fractionated radiation must be targeted at either the intact prostate or the prostate fossa (surgical bed) in cases of prior prostatectomy.
- Radiation fields may also include treatment of the pelvic lymph node basins and/or more distant targets including but not limited to nearby bone metastases and retroperitoneal lymph nodes.
- Brachytherapy boost prior or subsequent to external beam radiation course is allowed.
Key exclusion criteria (8 listed)
- Participants who are unable or unwilling to return for future visits to assess toxicity changes.
- Participants lacking the functional capacity required to report and describe their symptoms.
- Participants who are unable to swallow pills or have known allergy/adverse reaction to Boswellia.
- Participants with known moderate to severe liver disease.
- Participants taking medications which may interfere with the administration of Boswellia per the treating physician.
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 |
|---|---|---|
| Boswellia serrata extractAlso: Indian FrankincenseBoswellia 1500 mg three times per day, taken orally for up to 10 weeks | Drug | Boswellia |
Primary outcome
Improvements in genitourinary (GU) toxicity from prostate radiation after the initiation of Boswellia as assessed by changes in patient reported outcomes
Time frame: 1 week after initiation of oral Boswellia treatment.
The primary outcome endpoint will be the percentage of participants who experience improvement in urinary toxicity with Boswellia at the 1-week timepoint after a minimum of 2 days of treatment as determined by participants who mark "Improved" in response to the questionnaire item: "How have your urinary symptoms changed since starting Boswellia?" at the first weekly assessment.
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 9 Oct 2026.
- Background: PubMed 31643176LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547852/
- Background: PubMed 31234670Alluri VK, Dodda S, Kilari EK, Golakoti T, Sengupta K. Toxicological Assessment of a Standardized Boswellia serrata Gum Resin Extract. Int J Toxicol. 2019 Sep/Oct;38(5):423-435. doi: 10.1177/1091581819858069. Epub 2019 Jun 24.
- Background: PubMed 25448323Shang Y, Cui D, Yi S. Opening tight junctions may be key to opening the blood-prostate barrier. Med Sci Monit. 2014 Dec 2;20:2504-7. doi: 10.12659/MSM.890902.
- Background: PubMed 16223251Reising K, Meins J, Bastian B, Eckert G, Mueller WE, Schubert-Zsilavecz M, Abdel-Tawab M. Determination of boswellic acids in brain and plasma by high-performance liquid chromatography/tandem mass spectrometry. Anal Chem. 2005 Oct 15;77(20):6640-5. doi: 10.1021/ac0506478.
- Background: PubMed 34412175Kulkarni PD, Damle ND, Hingorani L, Bhaskar VH, Ghante MR, Patil A, Gurjar M, Gota V. Pharmacokinetics of solid lipid Boswellia serrata particles in healthy subjects. Drug Metab Pers Ther. 2021 Apr 5;36(3):215-221. doi: 10.1515/dmpt-2020-0176.
- Background: PubMed 41341032Peng C, Yang Y, Wang Y, Gong B, Sun X, Yang X. From bench to bedside, boswellic acids in anti-inflammatory therapy - mechanistic insights, bioavailability challenges, and optimization approaches. Front Pharmacol. 2025 Nov 18;16:1692443. doi: 10.3389/fphar.2025.1692443. eCollection 2025.
- Background: PubMed 35509480Presicce F, Barrese F, Cantiani A, Filianoti A, Tuzzolo D, Di Palma P, Lauretti S, Brunori S, Martini M. Boswellia resin extract and propolis derived polyphenols in patients with type III chronic prostatitis/chronic pelvic pain syndrome: An Italian prospective multicenter study. Asian J Urol. 2022 Apr;9(2):139-145. doi: 10.1016/j.ajur.2021.09.002. Epub 2021 Sep 11.
- Background: PubMed 28903409Schmidt C, Loos C, Jin L, Schmiech M, Schmidt CQ, Gaafary ME, Syrovets T, Simmet T. Acetyl-lupeolic acid inhibits Akt signaling and induces apoptosis in chemoresistant prostate cancer cells in vitro and in vivo. Oncotarget. 2017 Jul 8;8(33):55147-55161. doi: 10.18632/oncotarget.19101. eCollection 2017 Aug 15.
- Background: PubMed 19567671Pang X, Yi Z, Zhang X, Sung B, Qu W, Lian X, Aggarwal BB, Liu M. Acetyl-11-keto-beta-boswellic acid inhibits prostate tumor growth by suppressing vascular endothelial growth factor receptor 2-mediated angiogenesis. Cancer Res. 2009 Jul 15;69(14):5893-900. doi: 10.1158/0008-5472.CAN-09-0755. Epub 2009 Jun 30.
- Background: PubMed 18281494Lu M, Xia L, Hua H, Jing Y. Acetyl-keto-beta-boswellic acid induces apoptosis through a death receptor 5-mediated pathway in prostate cancer cells. Cancer Res. 2008 Feb 15;68(4):1180-6. doi: 10.1158/0008-5472.CAN-07-2978.
- Background: PubMed 12182991Coleman CN, Kelly L, Riese Daly N, Beard C, Kaplan I, Lamb C, Propert K, Manola J. Phase III study of ibuprofen versus placebo for radiation-induced genitourinary side effects. Int J Radiat Oncol Biol Phys. 2002 Sep 1;54(1):191-4. doi: 10.1016/s0360-3016(02)02907-3.
- Background: PubMed 15850917Elshaikh MA, Ulchaker JC, Reddy CA, Angermeier KW, Klein EA, Chehade N, Altman A, Ciezki JP. Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):164-9. doi: 10.1016/j.ijrobp.2004.09.036.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Boswellia serrata extract in people with Prostate Cancer, run by Brigham and Women's Hospital.
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 10 inclusion and 8 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 9 Oct 2026. 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?
Contact Riley Maddox (5084883898, rmaddox@Bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in genitourinary (GU) toxicity from prostate radiation after the initiation of Boswellia as assessed by changes in patient reported outcomes (time frame: 1 week after initiation of oral Boswellia treatment.). 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 NCT07867158, which also lists 16 linked publications.
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 Oct 2026.