SpaceIT Hydrogel System for Perirectal Spacing in Subjects with Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT): A Multicenter Randomized Controlled Clinical Study (HYDROSPACE)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Prostate Cancer
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male
  • Other Inclusion Criteria:
    1. Subjects must have had pathologically confirmed (by routine hematoxylin and eosin [H&E] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
    2. Clinical stage T1-T2c (AJCC Ver. 8) tumor
    3. Demonstrated blood prostate specific antigen (PSA) levels =20 ng/ml as measured within 6 months of the Baseline visit and prior to commencing androgen deprivation therapy (ADT)

You may not be eligible for this study if the following are true:

    1. Subjects who are planning to undergo brachytherapy or focal boost
    2. Subjects who have magnetic resonance imaging (MRI) evidence of gross posterior extracapsular extension (ECE) of the prostate cancer
    3. Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned



If you are registered as a volunteer, please log in to contact the study team/express interest in this study.