A Phase II Randomized Controlled Trial of Stereotactic Ablative Body Radiotherapy (SAbR) With or Without Neurovascular Sparing for Erectile Function Preservation in Localized Prostate Cancer

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A Phase II Randomized Controlled Trial of Stereotactic Ablative Body Radiotherapy (SAbR) With or Without Neurovascular Sparing for Erectile Function Preservation in Localized Prostate Cancer

Condition: Prostate Cancer Adenocarcinoma

Intervention:

  • Radiation: 30Gy (Gray) planning target volume (PTV)

Purpose: Reduction of dose to or ‘sparing’ of neurovascular structures during stereotactic ablative body radiotherapy (SAbR) for localized prostate cancer will improve retention of sexual potency, while retaining excellent oncologic control and other secondary health-related quality of life (HRQOL) endpoints. Primary Objectives: • To compare the decline in patient health-related quality of life (HRQOL) instrument-defined erectile dysfunction following stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing Secondary Objectives: – Assess acute (within 9 months of treatment) and chronic (>9 months after treatment) SAbR related GU and GI toxicities, as well as serial impact on HRQOL metrics over time – Assess biochemical progression free survival, local recurrence, disease-specific survival – Evaluate the impact of neurovascular sparing on neurovascular element dose and the impact of rectal spacer use on neurovascular element sparing – Evaluate quality of spacer placement and its effect on dose to neurovascular structures – Evaluate rate local recurrence in the area of sparing adjacent to the neurovascular elements by biopsy in those with biochemical progression. – Evaluate simplified ‘practical’ secondary HRQOL sexual potency endpoints that can be compared to prior literature.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03525262

Sponsor: University of Texas Southwestern Medical Center

Primary Outcome Measures:

  • Measure: Reduction in Expanded prostate cancer index composite (EPIC) sexual function domain composite score from Baseline
  • Time Frame: Mean 24-Months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Acute & Delayed Genitourinary (GU) and Gastrointestinal (GI) toxicity
  • Time Frame: Mean 24-Months
  • Safety Issue:
  • Measure: Biochemical failure RTOG-ASTRO definition (also known as Phoenix definition)
  • Time Frame: 60 Months
  • Safety Issue:

Estimated Enrollment: 120

Study Start Date: April 24, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 120 Years
  • Gender: Male

Inclusion Criteria:

  • Appropriate staging studies identifying patient as American Joint Committee on Cancer (AJCC) 7th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of the prostate gland. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. See Appendix I for details on AJCC 7th Edition staging criteria. Histologic confirmation of cancer will be required by biopsy performed within 12 months of registration. T-staging may be assessed by multi-parametric imaging alone if digital rectal examination was deferred.
  • The patient’s Zubrod performance status must be 0-2 (see Appendix II for definition).
  • The Gleason summary score should be less than or equal to 7 [Grade group 1 (Gleason 3+3=6), group 2 (Gleason 3+4=7), and group 3 (Gleason 4+3=7) are allowed]. See Appendix III for details on definitions. While a template biopsy is recommended, it is not required in the case of MRI fusion biopsy performed on all dominant MR lesions (defined as Prostate imaging
  • reporting and data system (PIRADS) v2 4-5).
  • Baseline AUA symptom score ≤19 (see Appendix IV for questionnaire) without need for maximum medical therapy (specifically, not on tamsulosin 0.8mg daily)
  • EPIC sexual domain composite score 60-100 (see Appendix V)
  • Multi-parametric MRI evaluation of the prostate is required for this study within 90 days of registration. Gross radiographic disease on MRI (defined as PIRADS v2 score 3-5) must be > 5mm at minimum distance from at least one side’s neurovascular bundle, which is typically the closest of the neurovascular elements to the prostate.
  • The serum PSA should be less than or equal to 20 ng/ml within 90 days of registration.
  • Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT or anti-androgen therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride; (5) within 5 days of a digital rectal examination.
  • Ultrasound or MRI based volume estimation of prostate gland ≤ 80 grams. Cytoreduction therapy (finasteride or dutasteride only) may be considered for those with >60 gram size.
  • All patients must be willing and capable to provide informed consent to participate in the protocol within the 30 days prior to registration

Exclusion Criteria:

  • Subjects with clinical (digital rectal examination) evidence of extraprostatic extension (T3a) or seminal vesicle involvement (T3b). MRI evidence of equivocal/potential but not definite extraprostatic extension is allowed, as long as it is unilateral and not on the side of the gland proposed for neurovascular element sparing. In equivocal cases of potential extracapsular extension on MRI only, discretion is left to the treating physician.
  • MRI evidence of gross disease (defined as PIRADS v2 score 3-5 lesions) ≤5mm of BOTH neurovascular bundles, which are the most proximate of the neurovascular elements planned for sparing on this protocol.
  • Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7, clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy cores positive for cancer are ineligible.
  • Inability to undergo multi-parametric MRI.
  • Evidence of metastatic disease. Note bone scan is not required for this study given the low-intermediate NCCN risk cohort to be enrolled.
  • Evidence of clinical nodal involvement of the pelvis. Biopsy is required for lymph nodes over ≥1.5cm in short-axis measured size.
  • No current ADT or anti-androgen therapy at time of registration is allowed. Further, no more than 3 cumulative months of prior ADT or anti-androgen therapy is allowed. If either has been used by the patient, there must be a demonstration of full testosterone recovery (>280ng/dL serum blood level), EPIC sexual domain score ≥60, and at least 1 month between demonstration of testosterone recovery and study registration (any one measurement of testosterone recovery suffices).
  • Testosterone ≤ 280 ng/dL (any one measurement >280 ng/dL suffices for inclusion)
  • 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 ablative procedures to the prostate for benign prostatic hyperplasia or other conditions (i.e. cryotherapy, HIFU).
  • Subjects who have baseline severe urinary symptoms, as defined by AUA symptom score >19 (alpha-blocker medication allowed except if taking tamsulosin 0.8mg daily at baseline which indicates compensated severe symptoms and also can affect sexual function).
  • Subjects who have a history of significant psychiatric illness that would confound informed consent.
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
  • Patients with active inflammatory colitis (including Crohn’s Disease and ulcerative colitis) currently requiring systemic steroids and/or systemic immunosuppression are not eligible.
  • Subjects with a known allergy to polyethylene glycol hydrogel (rectal spacer material) or contraindication to spacer products (Duraseal or SpaceOAR)
  • Subjects with uncontrolled coagulation disorder which cannot be controlled with anticoagulants
  • Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
  • Men who require erectile function medication or aid to achieve an erection sufficient for intercourse. Ability to achieve erection sufficient for intercourse without medication or aid at least once time in the month prior to registration is sufficient for inclusion.
  • Men who have clinically significant penile malformation (i.e. Peyronie’s disease) or history of penile implantation are excluded.
  • If DRE is performed, patient may not have palpable disease on side of gland to be planned for neurovascular sparing. Given the poor accuracy of DRE, such a finding should be confirmed by MRI and/or biopsy to harbor actual disease before excluding a patient on this basis.

Contact:

  • Neil B Desai, MD MHS
  • Neil.Desai@UTSouthwestern.edu
  • 2146458525

Locations:

  • University of Colorado Hospital
  • Aurora Colorado 80045 United States
  • UT Southwestern Cancer Center
  • Dallas Texas 75235 United States

View trial on ClinicalTrials.gov

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