A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy

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A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy

Condition: Prostate Cancer

Intervention:

  • Radiation: Brachytherapy
  • Other: Hyperthermia

Purpose: Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03238066

Sponsor: University of Erlangen-Nürnberg Medical School

Primary Outcome Measures:

  • Measure: Rate of late GI/GU grade 3 and more toxicities
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Rate of acute GI/GU treatment-related adverse events
  • Time Frame: up to 24 months after start of recruitment
  • Safety Issue:
  • Measure: Time to biochemical failure
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Disease-free survival
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Disease-specific survival
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:
  • Measure: Clinical patterns of tumor recurrence
  • Time Frame: up to 60 Months in Follow up
  • Safety Issue:

Estimated Enrollment: 77

Study Start Date: April 2015

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

Contact:

  • Vratislav Strnad, MD
  • ++49(0)9131-85 Ext. 33419

Locations:

  • Strahlenklinik im Universitaetsklinikum Erlangen
  • Erlangen 91054 Germany
  • Centrum Radiotherapii
  • Kraków 31-826 Poland
  • Maria Sklodowska-Curie Institute – Oncology Center
  • Warszaw 02-034 Poland

View trial on ClinicalTrials.gov

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