Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01583920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2012-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2012-04-20', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute urinary and rectal toxicities', 'timeFrame': 'Acute period (<6 months)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v4.0'}], 'secondaryOutcomes': [{'measure': 'Incidence of late urinary and rectal toxicities', 'timeFrame': 'Late period (>6 months)', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v4.0'}, {'measure': 'Biochemical (ie. prostate specific antigen) disease free survival', 'timeFrame': '5 years'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': '5 years', 'description': 'Expanded Prostate Cancer Index Composite (EPIC)'}, {'measure': 'Acute and late urinary toxicities', 'timeFrame': '5 years', 'description': 'American Urological Association Symptom Index Score (i.e. IPSS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostatic neoplasms', 'brachytherapy', 'salvage therapy', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '40789422', 'type': 'DERIVED', 'citation': 'Paulin G, Morton G, Loblaw A, Tseng CL, Corkum M, Murgic J, Ravi A, Davidson M, Wronski M, Paudel M, Haider M, Deabreu A, Zhang L, Chung HT. Updated results of MR-assisted focal salvage HDR prostate brachytherapy: a prospective study. Radiother Oncol. 2025 Oct;211:111091. doi: 10.1016/j.radonc.2025.111091. Epub 2025 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-confirmed locally recurrent prostate adenocarcinoma \\> 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy\n* Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy\n* Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases\n* American Urological Association Symptom Index Score (ie. IPSS) \\< 15\n* Baseline (post-XRT) serum PSA \\< 10 ng/mL\n* Prostate volume as measured by transrectal ultrasound (TRUS) \\< 50cc\n* ECOG performance status 0-1\n\nExclusion Criteria:\n\n* Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma\n* Evidence of castrate resistance (defined as PSA \\> 3 ng/mL while testosterone is \\< 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.'}, 'identificationModule': {'nctId': 'NCT01583920', 'briefTitle': 'Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Pilot Study of Focal Salvage HDR Prostate Brachytherapy', 'orgStudyIdInfo': {'id': 'clinicaltrials_hchu_042012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Focal salvage HDR prostate brachytherapy', 'interventionNames': ['Radiation: focal salvage HDR prostate brachytherapy']}], 'interventions': [{'name': 'focal salvage HDR prostate brachytherapy', 'type': 'RADIATION', 'description': 'Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.', 'armGroupLabels': ['Focal salvage HDR prostate brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre, Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Hans Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre, Odette Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Association of Radiation Oncology', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Hans Chung', 'investigatorFullName': 'Dr. Hans Chung', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}