HDR Brachytherapy, EBRT and STAD for the Treatment of Prostate Cancer

NCT03553602 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 210546
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Prostate Cancer - Recurrent

Keywords

Prostate Cancer; HDR brachytherapy; Recurrent Prostate Cancer; Oligometastasis; Salvage Brachytherapy; Salvage Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (1)

• Gastrointestinal Toxicity

  24 months

Study Arms (1)

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 \[until the end of radiotherapy\])

Drug: HDR Brachytherapy + EBRT + STAD

Interventions

HDR Brachytherapy + EBRT + STAD DRUG

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\[until end of radiotherapy\])

HDR Brachytherapy + EBRT + STAD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (25)

• 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.

  PMID: 8970487 BACKGROUND

• Simon 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.

  PMID: 2702835 BACKGROUND

• Savir-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.

  PMID: 28267449 BACKGROUND

• Suardi 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.

  PMID: 24571959 BACKGROUND

• Lin D, Wei L, Ying Z. Checking the Cox Model with Cumulative Sums of Martingale-Based Residuals. Biometrika. 1993;80:557-572.

  BACKGROUND

• 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.

  PMID: 21840116 BACKGROUND

• Chen 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.

  PMID: 23474112 BACKGROUND

• Yamada 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.

  PMID: 24373762 BACKGROUND

• Crook J, Pisansky TM, Clinic M, et al. Nrg Oncology Rtog 0526.; 1818.

  BACKGROUND

• 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.

  PMID: 10565751 BACKGROUND

• Grado 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.

  PMID: 9886580 BACKGROUND

• Parekh 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.

  PMID: 23763889 BACKGROUND

• Michalski 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.

  BACKGROUND

• 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.

  PMID: 17007995 BACKGROUND

• Ahmadi 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.

  PMID: 25045284 BACKGROUND

• Zumsteg ZS, Spratt DE, Romesser PB, Pei X, Zhang Z, Kollmeier M, McBride S, Yamada Y, Zelefsky MJ. Anatomical Patterns of Recurrence Following Biochemical Relapse in the Dose Escalation Era of External Beam Radiotherapy for Prostate Cancer. J Urol. 2015 Dec;194(6):1624-30. doi: 10.1016/j.juro.2015.06.100. Epub 2015 Jul 10.

  PMID: 26165583 BACKGROUND

• Zelefsky MJ, Kuban DA, Levy LB, Potters L, Beyer DC, Blasko JC, Moran BJ, Ciezki JP, Zietman AL, Pisansky TM, Elshaikh M, Horwitz EM. Multi-institutional analysis of long-term outcome for stages T1-T2 prostate cancer treated with permanent seed implantation. Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):327-33. doi: 10.1016/j.ijrobp.2006.08.056. Epub 2006 Nov 2.

  PMID: 17084558 BACKGROUND

• Shipley WU, Thames HD, Sandler HM, Hanks GE, Zietman AL, Perez CA, Kuban DA, Hancock SL, Smith CD. Radiation therapy for clinically localized prostate cancer: a multi-institutional pooled analysis. JAMA. 1999 May 5;281(17):1598-604. doi: 10.1001/jama.281.17.1598.

  PMID: 10235152 BACKGROUND

• Demanes DJ, Martinez AA, Ghilezan M, Hill DR, Schour L, Brandt D, Gustafson G. High-dose-rate monotherapy: safe and effective brachytherapy for patients with localized prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1286-92. doi: 10.1016/j.ijrobp.2010.10.015. Epub 2011 Feb 9.

  PMID: 21310546 BACKGROUND

• Henriquez I, Sancho G, Hervas A, Guix B, Pera J, Gutierrez C, Abuchaibe O, Martinez-Monge R, Tormo A, Polo A. Salvage brachytherapy in prostate local recurrence after radiation therapy: predicting factors for control and toxicity. Radiat Oncol. 2014 Apr 30;9:102. doi: 10.1186/1748-717X-9-102.

  PMID: 24885287 BACKGROUND

• Tward JD, Kokeny KE, Shrieve DC. Radiation therapy for clinically node-positive prostate adenocarcinoma is correlated with improved overall and prostate cancer-specific survival. Pract Radiat Oncol. 2013 Jul-Sep;3(3):234-240. doi: 10.1016/j.prro.2012.11.011. Epub 2013 Jan 28.

  PMID: 24674370 BACKGROUND

• Meng MB, Wang HH, Zaorsky NG, Zhao XZ, Wu ZQ, Jiang B, Song YC, Zhuang HQ, Li FT, Zhao LJ, Wang CL, Li K, Wang P, Yuan ZY. Clinical evaluation of stereotactic radiation therapy for recurrent or second primary mediastinal lymph node metastases originating from non-small cell lung cancer. Oncotarget. 2015 Jun 20;6(17):15690-703. doi: 10.18632/oncotarget.3704.

  PMID: 25881546 BACKGROUND

• Parks J, Kloecker G, Woo S, Dunlap NE. Stereotactic Body Radiation Therapy as Salvage for Intrathoracic Recurrence in Patients With Previously Irradiated Locally Advanced Non-Small Cell Lung Cancer. Am J Clin Oncol. 2016 Apr;39(2):147-53. doi: 10.1097/COC.0000000000000039.

  PMID: 24457534 BACKGROUND

• Hearn JW, Videtic GM, Djemil T, Stephans KL. Salvage stereotactic body radiation therapy (SBRT) for local failure after primary lung SBRT. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):402-6. doi: 10.1016/j.ijrobp.2014.05.048. Epub 2014 Jul 10.

  PMID: 25017480 BACKGROUND

• Prostate Cancer Statistics. 2016.

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Abhishek Solanki
• Organization: Loyola University Medical Center

abhishek.solanki@lumc.edu

7082163930

Study Officials

• Abhishek Solanki, MD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: December 20, 2017
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)