Clinical trial · Interventional
Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy
A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy
NCT03238066CI-TRIAL-00033246Prostata-BT-HTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Hyperthermia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- The physician can choose either HDR or PDR brachytherapy. If HDR BT is chosen: d1: hyperthermia (IHT) 60 minutes + 10Gy HDR brachytherapy (HDRBT) d22: IHT 60 minutes + 10 Gy HDRBT d43: IHT 60 minutes + 10 Gy HDRBT If PDR BT is chosen: d1-3: IHT 60 minutes + 30Gy PDRBT d29-31: IHT 60 minutes + 30Gy PDRBT
- interventionNames
- Radiation: Brachytherapy
- Other: Hyperthermia
Primary outcomes (1)
- measure
- Rate of late GI/GU grade 3 and more toxicities
- timeFrame
- up to 60 Months in Follow up
Secondary outcomes (6)
- measure
- Rate of acute GI/GU treatment-related adverse events
- timeFrame
- up to 24 months after start of recruitment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed locally recurrent prostate cancer - biopsy performed \< 6 months before registration; * Histology: Adenocarcinoma, every Gleason score (2-10) * Initial treatment (EBRT) completed \> 24 months prior to biopsy; * Androgen deprivation therapy for prostate cancer should be discontinued at least 3 months prior to patient registration * Staging performed within 12 weeks prior to registration: * Local stage evaluated by DRE, TRUS or - if necessary - mpMRI (T1b, T1c, T2a, T2b, T2c, T3a, T3b); * Negative lymph nodes by imaging studies (at least one of these: choline PET scan, pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0); * Negative bone scan (M0); * PSA-DT \> 6 months (PSA measurements taken of the 12 months prior to registration) * Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS) \< 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers; * Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. In TRUS volume study performed 0-4 weeks before registration patient meets eligibility criteria for prostate brachytherapy as follows: * Prostate/tumor volume \<60ml * The distance rear prostate edge - rectal mucosa \>5mm * Interference of pubic arch ruled out * If local stage T3b: it must be possible to cover by the brachytherapy dose cancer infiltration * Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for 915 MHz frequency antennas) * The patient is suitable for spinal or general anesthesia * Age \> 18 y. * Life expectancy \> 5 years * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * The patient must sign a study-specific informed consent form before study registration Exclusion Criteria: * Severe, active comorbidities: * Decompensated congestive heart disease * Chronic obstructive pulmonary disease exacerbation, respiratory failure * Hepatic insufficiency resulting in coagulation defects or clinical jaundice * Other active malignancy or treatment of invasive or hematological malignancy * Evidence of extraprostatic disease at local recurrence: * Local stage T4 * Histologic or radiologic evidence of lymph node metastases (N1 or pN1) * Presence of distant metastases (M1) * Any of the following prior therapies: * TURP within 6 months prior to registration * Prostatic salvage cryosurgery performed at least 6 months before registration * HIFU performed at least 6 months before registration * Androgen deprivation therapy within 3 months prior to registration * Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
References
Publications (1)
- DERIVEDStrnad V, Dabkowski M, Dabrowski T, Brandys P, Kulik A, Gruszczynska E, Ott OJ, Strnad AR, Schmidt M, Lotter M, Kreppner S, Merten R, Fietkau R, Corradini S, Kukielka AM. Prospective Phase 2 Trial: Long-term results of a salvage brachytherapy combined with interstitial hyperthermia as Re-Irradiation for locally recurrent prostate Carcinoma. Radiother Oncol. 2026 May;218:111446. doi: 10.1016/j.radonc.2026.111446. Epub 2026 Feb 15. PMID 41702454