Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT03238066
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03238066
Study Brief:
Protocol Section:
NCT03238066