Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Intervention description: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Male
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose is to determine if use of rectal spacers are effective at improving protection of
      rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of
      acute effects. It is also to determine whether it provides sufficient dosimetric benefits to
      warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation)
      related clinical studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must be willing and capable to provide informed consent to participate in
             the protocol.

          -  Eligible patients must have appropriate staging studies identifying them as AJCC stage
             T1 (a, b, or c) or T2a or T2b adenocarcinoma of the prostate gland. The patient should
             not have direct evidence of regional or distant metastases after appropriate staging
             studies. Histologic confirmation of cancer will be required by biopsy performed within
             180 days of registration.

          -  The patient's Zubrod performance status must be 0-2.

          -  The Gleason score should be less than or equal to 6 or 3+4 if < 50% of a 12 core
             biopsy was involved.

          -  The serum PSA should be less than or equal to 10 ng/ml.

          -  Study entry PSA must not be obtained during the following time frames: 10 day period
             following prostate biopsy; following initiation of ADT; within 30 days after
             discontinuation of finasteride; or within 90 days after discontinuation of
             dutasteride.

          -  Age ≥ 18 years.

          -  Patients may have used prior hormonal therapy, but it should be limited to no more
             than 9 months of therapy prior to enrollment.

          -  The ultrasound, or CT based volume estimation of the patient's prostate gland should
             be ≤ 60 grams.

        Exclusion Criteria:

          -  Subjects who have had previous pelvic radiotherapy or have had chemotherapy or surgery
             for prostate cancer.

          -  Subjects who have plans to receive other concomitant or post treatment adjuvant
             antineoplastic therapy while on this protocol including surgery, cryotherapy,
             conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as
             part of the treatment of prostate cancer.

          -  Subjects who have undergone previous transurethral resection of the prostate (TURP) or
             cryotherapy to the prostate. Subjects who have significant urinary obstructive
             symptoms; AUA score must be ≤15 (alpha blockers allowed).

          -  Subjects who have a history of significant psychiatric illness.

          -  Men of reproductive potential who do not agree that they or their partner will use an
             effective contraceptive method such as condom/diaphragm and spermacidal foam,
             intrauterine device (IUD), or prescription birth control pills.

          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
             for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or
             cervix are all permissible).

          -  Severe, active co-morbidity, defined as follows:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the last 6 months.

               -  Transmural myocardial infarction within the last 6 months.

               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time
                  of registration.

               -  Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy within 30 days before
                  registration.

               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
                  note, however, that laboratory tests for liver function and coagulation
                  parameters are not required for entry into this protocol.

               -  Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition;
                  note, however, that HIV testing is not required for entry into this protocol. The
                  need to exclude patients with AIDS from this protocol is necessary because the
                  treatments involved in this protocol may be significantly immunosuppressive.
                  Protocol-specific requirements may also exclude immuno-compromised patients.

               -  Patients with history of inflammatory colitis (including Crohn's Disease and
                  Ulcerative colitis) are not eligible.

          -  Subjects with a known allergy to polyethylene glycol hydrogel (spacer material) or
             contraindication to spacer products (Duraseal or SpaceOAR).

          -  Subjects with evidence of extraprostatic extension (T3a) or seminal vesicle
             involvement (T3b) on clinical evaluation.