Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Purpose

The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.

Conditions

  • Prostate Cancer
  • Prostate Neoplasm

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of early stage prostate cancer. - Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA < 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores < 50%, no more than one NCCN intermediate risk factor). - Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant. - At least 18 years of age. - ECOG performance status ≤ 2 - Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria

  • Prior radiation therapy to the prostate or lower pelvis encompassing the prostate. - A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only. - Currently receiving any other investigational agents. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. - Unable to undergo general, spinal or local anesthesia. - Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HDR brachytherapy - 21 Gy 		-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy.
  • Radiation: HDR brachytherapy
    - Dose constraints for 21 Gy: - Bladder and rectum: V70 < 1 cc - Urethra: V115 < 1 cc - V135: 0% - Dose constraints for 23 Gy: - Bladder and rectum: V65 < 1 cc - Urethra: V105 < 1 cc - V125: 0% - Dose constraints for 25 Gy: - Prostate V100 >90% (>95% preferred) - Bladder and rectum: V70 < 1 cc, Dmax <115% - Urethra: V110 < 1 cc, Dmax <120%
Experimental
HDR brachytherapy - 23 Gy 		-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.
  • Radiation: HDR brachytherapy
    - Dose constraints for 21 Gy: - Bladder and rectum: V70 < 1 cc - Urethra: V115 < 1 cc - V135: 0% - Dose constraints for 23 Gy: - Bladder and rectum: V65 < 1 cc - Urethra: V105 < 1 cc - V125: 0% - Dose constraints for 25 Gy: - Prostate V100 >90% (>95% preferred) - Bladder and rectum: V70 < 1 cc, Dmax <115% - Urethra: V110 < 1 cc, Dmax <120%
Experimental
HDR brachytherapy - 25 Gy 		-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy.
  • Radiation: HDR brachytherapy
    - Dose constraints for 21 Gy: - Bladder and rectum: V70 < 1 cc - Urethra: V115 < 1 cc - V135: 0% - Dose constraints for 23 Gy: - Bladder and rectum: V65 < 1 cc - Urethra: V105 < 1 cc - V125: 0% - Dose constraints for 25 Gy: - Prostate V100 >90% (>95% preferred) - Bladder and rectum: V70 < 1 cc, Dmax <115% - Urethra: V110 < 1 cc, Dmax <120%

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Hiram A Gay, M.D.
314-362-8516
hiramgay@wustl.edu

More Details

NCT ID
NCT03424850
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Hiram A Gay, M.D.
314-362-8516
hiramgay@wustl.edu