Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05715502
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2022-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Focal Salvage Brachytherapy Study (FocaSaBra)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale', 'timeFrame': 'change from baseline to 24 months of follow-up', 'description': 'Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale - IPSS within 0-35 points'}, {'measure': 'Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5) (0-25 points)', 'timeFrame': 'change from baseline to 24 months of follow-up', 'description': 'Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5): scale 0-25 points'}, {'measure': 'Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols. (0-100 points)', 'timeFrame': 'change from baseline to 24 months of follow-up', 'description': 'Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols, scale: 0-100 points'}], 'secondaryOutcomes': [{'measure': 'Assessment of the adverse events in the percentage of grades with the CTCAE v4.0', 'timeFrame': '24 months after treatment', 'description': 'Assessment of the adverse events in the percentage of grades with the CTCAE v4.0 scale: 0-5 grades'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrence', 'prostate cancer', 'brachytherapy', 'focal treatment', 'salvage treatment', 'radiotherapy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '33545689', 'type': 'BACKGROUND', 'citation': "Schaeffer E, Srinivas S, Antonarakis ES, Armstrong AJ, Bekelman JE, Cheng H, D'Amico AV, Davis BJ, Desai N, Dorff T, Eastham JA, Farrington TA, Gao X, Horwitz EM, Ippolito JE, Kuettel MR, Lang JM, McKay R, McKenney J, Netto G, Penson DF, Pow-Sang JM, Reiter R, Richey S, Roach Iii M, Rosenfeld S, Shabsigh A, Spratt DE, Teply BA, Tward J, Shead DA, Freedman-Cass DA. NCCN Guidelines Insights: Prostate Cancer, Version 1.2021. J Natl Compr Canc Netw. 2021 Feb 2;19(2):134-143. doi: 10.6004/jnccn.2021.0008."}, {'pmid': '27568654', 'type': 'BACKGROUND', 'citation': 'Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.'}, {'pmid': '17694553', 'type': 'BACKGROUND', 'citation': "Nguyen PL, D'Amico AV, Lee AK, Suh WW. Patient selection, cancer control, and complications after salvage local therapy for postradiation prostate-specific antigen failure: a systematic review of the literature. Cancer. 2007 Oct 1;110(7):1417-28. doi: 10.1002/cncr.22941."}, {'type': 'BACKGROUND', 'citation': 'Crook, J. M., Rodgers, J., Pisansky, T. M., Trabulsi, E., Amin, M., Bice, W., Morton, G., Pervez, N., Vigneault, E., Catton, C. N., Michalski, J. M., Roach, M., Beyer, D. C., Rossi, P. J., Horwitz, E. M., Donavanik, V., Sandler, H. M., Siva, S., Bressel, M., … Ball, D. (2020). Salvage Low Dose Rate Prostate Brachytherapy: Clinical Outcomes of a Phase II Trial for Local Recurrence after External Beam Radiotherapy (NRG/RTOG -0526). International Journal of Radiation Oncology, Biology, Physics, 108(3), S3. https://doi.org/10.1016/J.IJROBP.2020.07.2071'}, {'pmid': '30312717', 'type': 'BACKGROUND', 'citation': 'Crook JM, Zhang P, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Pervez N, Vigneault E, Catton C, Michalski J, Roach M 3rd, Beyer D, Jani A, Horwitz E, Donavanik V, Sandler H. A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526). Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):335-343. doi: 10.1016/j.ijrobp.2018.09.039. Epub 2018 Oct 9.'}, {'pmid': '19245439', 'type': 'BACKGROUND', 'citation': 'Aaronson DS, Yamasaki I, Gottschalk A, Speight J, Hsu IC, Pickett B, Roach M 3rd, Shinohara K. Salvage permanent perineal radioactive-seed implantation for treating recurrence of localized prostate adenocarcinoma after external beam radiotherapy. BJU Int. 2009 Sep;104(5):600-4. doi: 10.1111/j.1464-410X.2009.08445.x. Epub 2009 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with / without brachytherapy, hypofractionated, self-reactive HDR / LDR brachytherapy) with local recurrence on the part of the prostate gland.', 'detailedDescription': 'Prostate cancer is the second most common cancer among men in Poland. Currently, a large number of diagnosed patients undergo radical radiotherapy. Despite the high effectiveness of treatment, some patients experience failures in the form of regional and / or distant metastases, most often in the form of isolated local recurrence. In patients with suspected local recurrence, we can decide on emergency treatment after PET, pelvic MRI with an assessment of the prostate gland, and after excluding metastases. The oncological(NCCN ) and urological (EUA) recommendations allow salvage surgical treatment, observation, palliative pharmacological castration, or treatment using salvage brachytherapy.\n\nSalvage surgical treatment is associated with a 30-65% chance of cure in the top cancer centers in the world, and the risk of significant toxicity ranges from 17 to 48%.\n\nTreatment with brachytherapy, due to the intra-tissue nature and the short therapeutic range of radiation, can deliver a high dose to the treated area despite prior radiotherapy treatment and exhaustion of tolerance doses in critical organs, e.g., rectum and/or bladder. Treatment of the entire prostate gland gives a chance of disease-free survival for five years in approximately 65% of patients, according to the prospective study RTOG 0526. However, emergency treatment in this study was associated with a 14% risk of significant post-treatment toxicity requiring medical intervention. There are some reports in the literature on brachytherapy involving cancer in the part of the prostate gland (focal brachytherapy), but they are only retrospective. They show significant treatment efficacy and lower toxicity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy)\n* Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT\n* Exclusion of distant metastases using CT, MR, or PET imaging\n* PSA doubling time over six months\n* PSA value \\<10 ng / ml\n* No anti-androgen treatment in the year prior\n* Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points\n* General condition according to the WHO scale ≤ 2\n* Signing informed consent to participate in the study\n\nExclusion Criteria:\n\n* PSA value\\> 10ng / ml\n* General condition according to the WHO scale\\> 2\n* Dysuria on the IPSS scale\\> 20 points\n* PSA doubling time \\<6 months\n* Inability to discontinue anticoagulants.\n* An active urinary tract infection.\n* Contraindications to general anesthesia\n* Active inflammatory bowel diseases.\n* Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer\n* Estimated Survival \\<5 years'}, 'identificationModule': {'nctId': 'NCT05715502', 'acronym': 'FocaSaBra', 'briefTitle': 'Focal Salvage Brachytherapy Study (FocaSaBra)', 'organization': {'class': 'OTHER', 'fullName': 'The Greater Poland Cancer Centre'}, 'officialTitle': 'Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)', 'orgStudyIdInfo': {'id': 'FocaSaBra'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin.', 'interventionNames': ['Radiation: brachytherapy']}], 'interventions': [{'name': 'brachytherapy', 'type': 'RADIATION', 'description': 'Radiation: focal low dose rate or high dose rate brachytherapy for the lesion with appropriate margin, defined in magnetic resonance or positron emission tomography All recruited participants will be treated with interstitial brachytherapy for local recurrence of prostate cancer. The low dose rate of brachytherapy is used with a total dose of 145 Gy in the clinical target volume for participants after hypofractionated radiotherapy, a high dose rate brachytherapy as monotherapy or boost with external beam radiotherapy The high dose rate brachytherapy with two fractions of 13 Gy in the clinical target volume with a 3 to 14 days break is used after primary low dose rate brachytherapy or external beam radiotherapy alone.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-866', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Wojciech Burchardt, Phd, MD', 'role': 'CONTACT', 'email': 'wojciech.burchardt@wco.pl', 'phone': '+48505149659'}, {'name': 'Ewa Tańska, PhD, MSc.', 'role': 'CONTACT', 'email': 'ewa.tanska@wco.pl', 'phone': '+618850767'}], 'facility': 'Greater Poland Cancer Centre / Brachytherapy Department', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Wojciech Burchardt, PhD, MD', 'role': 'CONTACT', 'email': 'wojciech.burchardt@wco.pl', 'phone': '+48505149659'}, {'name': 'Ewa Tańska, PhD, MSc.', 'role': 'CONTACT', 'email': 'ewa.tanska@wco.pl', 'phone': '+618850767'}], 'overallOfficials': [{'name': 'Wojciech Burchardt, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Greater Poland Cancer Centre / Brachytherapy Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Greater Poland Cancer Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}