Prostate Cancer - RecurrentPhase 1/2BEACONNCT03553602
HDR Brachytherapy, EBRT and STAD for the Treatment of Prostate Cancer
A Phase 1/2 study testing HDR Brachytherapy + EBRT + STAD in people with Prostate Cancer - Recurrent, run by Loyola University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate cancer that has come… Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer - Recurrent
- What is being tested?
- HDR Brachytherapy + EBRT + STAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 26 Jul 2024
- Phase
- Phase 1/2
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
- Initial cancer diagnosis that fits these specific criteria:
- Stages cT1-T3a
- Nx or N0
- Mx or M0
- Eligible initial definitive radiotherapy modalities include:
Show all 17Show fewer
- External beam radiotherapy, with photon or proton beam therapy
- Definitive Brachytherapy
- Stereotactic Body Radiotherapy
- Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases
- Candidate for hormonal therapy.
- Current ECOG Performance status Scale 0-2 (Appendix D)
- Current International Prostate Symptom Score (IPSS) < 20 (Appendix B)
- Age >18
- The patient must be medically suitable to receive general or spinal anesthesia.
- AST, ALT, and alkaline phosphatase < 2 x upper institutional limit within 3 months of registration.
- The patient must be able and willing to sign a study-specific written informed consent form before study entry.
Who cannot join
- Preregistration radiation-related GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
- Treatment to a "whole pelvis" field with initial radiotherapy
- Patients with distant metastases (such as to the bone, visceral organs, and lymph nodes other than the pelvic nodes including the common iliac nodes).
- Patients receiving any other investigational agents.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
- Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: A Phase I/II Study of Salvage High-dose-rate Brachytherapy, ExternAl Beam COmbined and Short-term Hormonal Therapy for the Treatment of Node-positive Locally Recurrent Prostate Cancer After Prior Definitive Radiotherapy
The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate cancer that has come back in the prostate and pelvic lymph nodes after prior radiotherapy. The study will examine the side effects of the treatment as well as the ability of the treatment to get rid of the cancer. This involves the placement of a radioactive material in the affected area of the prostate temporarily, and then is subsequently removed using a minimally invasive technique. Participants will also receive external radiation for 5 weeks targeting the pelvis and giving a higher dose each day to the suspicious lymph nodes on PET scan. Radiation therapy will start approximately 2 months after the start of the Androgen Deprivation Therapy (hormone therapy). The hormone therapy consists of two medications, an oral medication taken daily 2 months before starting radiation therapy until the last of the radiation therapy and an injection of a medication which is given 2 months prior to the start of radiation. Patient are then followed at specific time intervals to evaluate the treatment side effects and cancer control
Read the detailed description
Salvage regional and local radiation is frequently utilized across multiple disease sites in oncology for patients who have failed initial radiotherapy. However, in prostate cancer, due to the concern that nodal involvement is a manifestation of widespread distant disease, this type of approach has not typically been pursued. However, with newer imaging modalities such as fluciclovine PET, PSMA pet, and C11 PET, physicians are identifying nodal disease and excluding distant disease better than they ever have before. Thus, in the modern era regional control may translate to improved long-term biochemical control, and prevent the morbidity and mortality associated with clinical progression of recurrent prostate cancer
Thus, in patients who recur both in the prostate and in the pelvic lymph nodes, treating both with radiation could result in meaningful clinical efficacy for patients-similar to other disease sites. However, there are limited data exploring the feasibility and safety of this combination. Therefore, the investigators are conducting this trial, which combines salvage HDR brachytherapy to the local recurrence of the prostate cancer with EBRT to the pelvic lymph nodes, and short-term hormonal therapy, in this group of patients. The investigators hypothesize that this approach can safely be performed without excess toxicity.
Once a patient is deemed eligible for the study and has signed the informed consent form, the patient will start hormone therapy with a LHRH Agonist medication which is an intramuscular injection which patients will receive every 3-6 months for 6 months. Within 10 days of the LHRH injection the patient must start an anti-androgen pill and will take the pill once a day until the last day of radiation. Radiation Therapy will start approximate 2 months after the start of the hormone therapy. Patients will undergo 2 implants with 1 fraction of 12 Gy delivered with each implant, scheduled 1-2 weeks apart when possible, although longer or shorter intervals are acceptable with PI approval. The implant procedure will be done under general anesthesia. Patients will also receive the external beam radiotherapy (for 5 weeks), starting before or after the brachytherapy treatment. Patients will also be asked to complete 2 short quality of life questionnaires before they receive treatment and at follow up visits. Patient will follow up with the radiation oncologist for an exam at 1 month, 3 months, 6 months and 12 months after treatment and then every 6 months for 4 more years then annually thereafter.
- Conditions
- Prostate Cancer - Recurrent
- Being tested
- HDR Brachytherapy + EBRT + STAD
- Keywords
- Prostate Cancer, HDR brachytherapy, Recurrent Prostate Cancer, Oligometastasis, Salvage Brachytherapy, Salvage Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR Brachytherapy + EBRT + STADDrug
HDR Brachytherapy implant: 2 fractions of 12 Gy to the prostate/ proximal SV.
EBRT: 50.4 Gy in 28 fractions to the pelvic lymph nodes +/- para-aortic nodes, with SIB up to 70 Gy to the PET- positive lesions.
6 months hormonal therapy(LHRH agonist and anti-androgen[until end of radiotherapy])
| Study group | Role | What they receive |
|---|---|---|
| HDR Brachytherapy + EBRT + STAD | Experimental | Day 1: HDR Brachytherapy implant: 2 fractions of 12 Gy to prostate/ proximal SV.
EBRT: 50.4 Gy in 28 fractions to the pelvic lymph nodes +/- para-aortic nodes, with SIB up to 70 Gy to the PET positive lesions.
6 months hormonal therapy(LHRH agonist and antiandrogen [until the end of radiotherapy]) Receives: Drug: HDR Brachytherapy + EBRT + STAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genitourinary Toxicity
The primary outcome in this study is the number of participants with an acute grade ≥3 radiation-related genitourinary toxicity as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: 24 months
Secondary outcomes (1)
Gastrointestinal Toxicity
A secondary outcome in this study is the number of participants with an acute grade ≥3 radiation-related gastrointestinal toxicity as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
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 posted12 Jun 2018
- Study start20 Dec 2017
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Why it stopped: The study was stopped for feasibility
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 (25)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer - RecurrentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhishek A. Solanki, Loyola University
- Investigators
- Abhishek Solanki, MD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553602
- Sponsor's protocol ID
- 210546
- Acronym
- BEACON
- Status last verified
- Jan 2026
- First submitted
- 30 May 2018
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.
PubMed 8970487Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
PubMed 2702835Savir-Baruch B, Zanoni L, Schuster DM. Imaging of Prostate Cancer Using Fluciclovine. PET Clin. 2017 Apr;12(2):145-157. doi: 10.1016/j.cpet.2016.11.005. Epub 2017 Jan 23.
PubMed 28267449Suardi N, Gandaglia G, Gallina A, Di Trapani E, Scattoni V, Vizziello D, Cucchiara V, Bertini R, Colombo R, Picchio M, Giovacchini G, Montorsi F, Briganti A. Long-term outcomes of salvage lymph node dissection for clinically recurrent prostate cancer: results of a single-institution series with a minimum follow-up of 5 years. Eur Urol. 2015 Feb;67(2):299-309. doi: 10.1016/j.eururo.2014.02.011. Epub 2014 Feb 18.
PubMed 24571959Lin D, Wei L, Ying Z. Checking the Cox Model with Cumulative Sums of Martingale-Based Residuals. Biometrika. 1993;80:557-572.
Rigatti P, Suardi N, Briganti A, Da Pozzo LF, Tutolo M, Villa L, Gallina A, Capitanio U, Abdollah F, Scattoni V, Colombo R, Freschi M, Picchio M, Messa C, Guazzoni G, Montorsi F. Pelvic/retroperitoneal salvage lymph node dissection for patients treated with radical prostatectomy with biochemical recurrence and nodal recurrence detected by [11C]choline positron emission tomography/computed tomography. Eur Urol. 2011 Nov;60(5):935-43. doi: 10.1016/j.eururo.2011.07.060. Epub 2011 Aug 3.
PubMed 21840116Chen CP, Weinberg V, Shinohara K, Roach M 3rd, Nash M, Gottschalk A, Chang AJ, Hsu IC. Salvage HDR brachytherapy for recurrent prostate cancer after previous definitive radiation therapy: 5-year outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):324-9. doi: 10.1016/j.ijrobp.2013.01.027. Epub 2013 Mar 6.
PubMed 23474112Yamada Y, Kollmeier MA, Pei X, Kan CC, Cohen GN, Donat SM, Cox BW, Zelefsky MJ. A Phase II study of salvage high-dose-rate brachytherapy for the treatment of locally recurrent prostate cancer after definitive external beam radiotherapy. Brachytherapy. 2014 Mar-Apr;13(2):111-6. doi: 10.1016/j.brachy.2013.11.005. Epub 2013 Dec 25.
PubMed 24373762Crook J, Pisansky TM, Clinic M, et al. Nrg Oncology Rtog 0526.; 1818.
Beyer DC. Permanent brachytherapy as salvage treatment for recurrent prostate cancer. Urology. 1999 Nov;54(5):880-3. doi: 10.1016/s0090-4295(99)00241-1.
PubMed 10565751Grado GL, Collins JM, Kriegshauser JS, Balch CS, Grado MM, Swanson GP, Larson TR, Wilkes MM, Navickis RJ. Salvage brachytherapy for localized prostate cancer after radiotherapy failure. Urology. 1999 Jan;53(1):2-10. doi: 10.1016/s0090-4295(98)00492-0.
PubMed 9886580Parekh A, Graham PL, Nguyen PL. Cancer control and complications of salvage local therapy after failure of radiotherapy for prostate cancer: a systematic review. Semin Radiat Oncol. 2013 Jul;23(3):222-34. doi: 10.1016/j.semradonc.2013.01.006.
PubMed 23763889Michalski JM, Pisansky TM, Lawton CAF, Potters L. Prostate Cancer. Clin Radiat Oncol. 2016:1038-1095.e18. doi:10.1016/B978-0-323-24098-7.00053-8.
Wirth MP, Hakenberg OW, Froehner M. Antiandrogens in the treatment of prostate cancer. Eur Urol. 2007 Feb;51(2):306-13; discussion 314. doi: 10.1016/j.eururo.2006.08.043. Epub 2006 Sep 11.
PubMed 17007995Ahmadi H, Daneshmand S. Androgen deprivation therapy for prostate cancer: long-term safety and patient outcomes. Patient Relat Outcome Meas. 2014 Jul 5;5:63-70. doi: 10.2147/PROM.S52788. eCollection 2014.
PubMed 25045284
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Salvage High-dose-rate Brachytherapy, ExternAl Beam COmbined and Short-term Hormonal Therapy for the Treatment of Node-positive Locally Recurrent Prostate Cancer After Prior Definitive Radiotherapy
- ClinicalTrials.gov ID
- NCT03553602
- Acronym / sponsor ID
- BEACON / 210546
- Conditions
- Prostate Cancer - Recurrent
- Keywords
- Prostate Cancer, HDR brachytherapy, Recurrent Prostate Cancer, Oligometastasis, Salvage Brachytherapy, Salvage Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped for feasibility
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate cancer that has come back in the prostate and pelvic lymph nodes after prior radiotherapy. The study will examine the side effects of the treatment as well as the ability of the treatment to get rid of the cancer. This involves the placement of a radioactive material in the affected area of the prostate temporarily, and then is subsequently removed using a minimally invasive technique. Participants will also receive external radiation for 5 weeks targeting the pelvis and giving a higher dose each day to the suspicious lymph nodes on PET scan. Radiation therapy will start approximately 2 months after the start of the Androgen Deprivation Therapy (hormone therapy). The hormone therapy consists of two medications, an oral medication taken daily 2 months before starting radiation therapy until the last of the radiation therapy and an injection of a medication which is given 2 months prior to the start of radiation. Patient are then followed at specific time intervals to evaluate the treatment side effects and cancer control
Detailed description
Salvage regional and local radiation is frequently utilized across multiple disease sites in oncology for patients who have failed initial radiotherapy. However, in prostate cancer, due to the concern that nodal involvement is a manifestation of widespread distant disease, this type of approach has not typically been pursued. However, with newer imaging modalities such as fluciclovine PET, PSMA pet, and C11 PET, physicians are identifying nodal disease and excluding distant disease better than they ever have before. Thus, in the modern era regional control may translate to improved long-term biochemical control, and prevent the morbidity and mortality associated with clinical progression of recurrent prostate cancer
Thus, in patients who recur both in the prostate and in the pelvic lymph nodes, treating both with radiation could result in meaningful clinical efficacy for patients-similar to other disease sites. However, there are limited data exploring the feasibility and safety of this combination. Therefore, the investigators are conducting this trial, which combines salvage HDR brachytherapy to the local recurrence of the prostate cancer with EBRT to the pelvic lymph nodes, and short-term hormonal therapy, in this group of patients. The investigators hypothesize that this approach can safely be performed without excess toxicity.
Once a patient is deemed eligible for the study and has signed the informed consent form, the patient will start hormone therapy with a LHRH Agonist medication which is an intramuscular injection which patients will receive every 3-6 months for 6 months. Within 10 days of the LHRH injection the patient must start an anti-androgen pill and will take the pill once a day until the last day of radiation. Radiation Therapy will start approximate 2 months after the start of the hormone therapy. Patients will undergo 2 implants with 1 fraction of 12 Gy delivered with each implant, scheduled 1-2 weeks apart when possible, although longer or shorter intervals are acceptable with PI approval. The implant procedure will be done under general anesthesia. Patients will also receive the external beam radiotherapy (for 5 weeks), starting before or after the brachytherapy treatment. Patients will also be asked to complete 2 short quality of life questionnaires before they receive treatment and at follow up visits. Patient will follow up with the radiation oncologist for an exam at 1 month, 3 months, 6 months and 12 months after treatment and then every 6 months for 4 more years then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDR Brachytherapy + EBRT + STAD | Experimental | Drug: HDR Brachytherapy + EBRT + STADDay 1: HDR Brachytherapy implant: 2 fractions of 12 Gy to prostate/ proximal SV. EBRT: 50.4 Gy in 28 fractions to the pelvic lymph nodes +/- para-aortic nodes, with SIB up to 70 Gy to the PET positive lesions. 6 months hormonal therapy(LHRH agonist and antiandrogen [until the end of radiotherapy]) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
- Initial cancer diagnosis that fits these specific criteria:
- Eligible initial definitive radiotherapy modalities include:
- Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases
- Candidate for hormonal therapy.
Key exclusion criteria (6 listed)
- Preregistration radiation-related GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
- Treatment to a "whole pelvis" field with initial radiotherapy
- Patients with distant metastases (such as to the bone, visceral organs, and lymph nodes other than the pelvic nodes including the common iliac nodes).
- Patients receiving any other investigational agents.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.
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 |
|---|---|---|
| HDR Brachytherapy + EBRT + STADHDR Brachytherapy implant: 2 fractions of 12 Gy to the prostate/ proximal SV. EBRT: 50.4 Gy in 28 fractions to the pelvic lymph nodes +/- para-aortic nodes, with SIB up to 70 Gy to the PET- positive lesions. 6 months hormonal therapy(LHRH agonist and anti-androgen[until end of radiotherapy]) | Drug | HDR Brachytherapy + EBRT + STAD |
Primary outcome
Genitourinary Toxicity
Time frame: 24 months
The primary outcome in this study is the number of participants with an acute grade ≥3 radiation-related genitourinary toxicity as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
1 secondary outcome
Gastrointestinal Toxicity
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8970487Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9. doi: 10.1016/s0895-4356(96)00236-3.
- Background: PubMed 2702835Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
- Background: PubMed 28267449Savir-Baruch B, Zanoni L, Schuster DM. Imaging of Prostate Cancer Using Fluciclovine. PET Clin. 2017 Apr;12(2):145-157. doi: 10.1016/j.cpet.2016.11.005. Epub 2017 Jan 23.
- Background: PubMed 24571959Suardi N, Gandaglia G, Gallina A, Di Trapani E, Scattoni V, Vizziello D, Cucchiara V, Bertini R, Colombo R, Picchio M, Giovacchini G, Montorsi F, Briganti A. Long-term outcomes of salvage lymph node dissection for clinically recurrent prostate cancer: results of a single-institution series with a minimum follow-up of 5 years. Eur Urol. 2015 Feb;67(2):299-309. doi: 10.1016/j.eururo.2014.02.011. Epub 2014 Feb 18.
- BackgroundLin D, Wei L, Ying Z. Checking the Cox Model with Cumulative Sums of Martingale-Based Residuals. Biometrika. 1993;80:557-572.
- Background: PubMed 21840116Rigatti P, Suardi N, Briganti A, Da Pozzo LF, Tutolo M, Villa L, Gallina A, Capitanio U, Abdollah F, Scattoni V, Colombo R, Freschi M, Picchio M, Messa C, Guazzoni G, Montorsi F. Pelvic/retroperitoneal salvage lymph node dissection for patients treated with radical prostatectomy with biochemical recurrence and nodal recurrence detected by [11C]choline positron emission tomography/computed tomography. Eur Urol. 2011 Nov;60(5):935-43. doi: 10.1016/j.eururo.2011.07.060. Epub 2011 Aug 3.
- Background: PubMed 23474112Chen CP, Weinberg V, Shinohara K, Roach M 3rd, Nash M, Gottschalk A, Chang AJ, Hsu IC. Salvage HDR brachytherapy for recurrent prostate cancer after previous definitive radiation therapy: 5-year outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):324-9. doi: 10.1016/j.ijrobp.2013.01.027. Epub 2013 Mar 6.
- Background: PubMed 24373762Yamada Y, Kollmeier MA, Pei X, Kan CC, Cohen GN, Donat SM, Cox BW, Zelefsky MJ. A Phase II study of salvage high-dose-rate brachytherapy for the treatment of locally recurrent prostate cancer after definitive external beam radiotherapy. Brachytherapy. 2014 Mar-Apr;13(2):111-6. doi: 10.1016/j.brachy.2013.11.005. Epub 2013 Dec 25.
- BackgroundCrook J, Pisansky TM, Clinic M, et al. Nrg Oncology Rtog 0526.; 1818.
- Background: PubMed 10565751Beyer DC. Permanent brachytherapy as salvage treatment for recurrent prostate cancer. Urology. 1999 Nov;54(5):880-3. doi: 10.1016/s0090-4295(99)00241-1.
- Background: PubMed 9886580Grado GL, Collins JM, Kriegshauser JS, Balch CS, Grado MM, Swanson GP, Larson TR, Wilkes MM, Navickis RJ. Salvage brachytherapy for localized prostate cancer after radiotherapy failure. Urology. 1999 Jan;53(1):2-10. doi: 10.1016/s0090-4295(98)00492-0.
- Background: PubMed 23763889Parekh A, Graham PL, Nguyen PL. Cancer control and complications of salvage local therapy after failure of radiotherapy for prostate cancer: a systematic review. Semin Radiat Oncol. 2013 Jul;23(3):222-34. doi: 10.1016/j.semradonc.2013.01.006.
- 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.
Abhishek Solanki, MD principal investigator
Loyola University Chicago
1 site 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 HDR Brachytherapy + EBRT + STAD in people with Prostate Cancer - Recurrent, run by Loyola University at 1 site 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 17 inclusion and 6 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 29 Jan 2026). 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?
Genitourinary Toxicity (time frame: 24 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 NCT03553602, which also lists 25 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 29 Jan 2026.