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Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.
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Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy:
Salvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22, 43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31) Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs should not exceed 43˚C
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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:
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
Exclusion criteria
Severe, active comorbidities:
Other active malignancy or treatment of invasive or hematological malignancy
Evidence of extraprostatic disease at local recurrence:
Any of the following prior therapies:
Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Primary purpose
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Interventional model
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77 participants in 1 patient group
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Central trial contact
Studiensekretariat; Vratislav Strnad, MD
Data sourced from clinicaltrials.gov
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