Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy (Prostata-BT-HT)

This is an interventional treatment trial for Prostate Cancer Read More

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.