Post-Prostatectomy Radiation with Stereotactic Ablative Radiotherapy (DAPPER)

Overview

About this study

The purpose of this study is to evaluate the feasibility, safety, and tolerability of post-prostatectomy SABR using daily adaptive radiation techniques.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Males age ≥ 18 years who are receiving post-operative radiation therapy to the prostate fossa, with or without inclusion of the pelvic lymph nodes, for biochemical
recurrences after radical prostatectomy.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.

- Ability to complete questionnaire(s) by themselves or with assistance.

- Provide written informed consent.

- Willingness and ability to complete protocol-specified follow-up (during the active monitoring phase of the study).

Exclusion Criteria:

- Current evidence of untreated metastatic prostate cancer involving nonregional lymph nodes outside of the bony pelvis, bone, or visceral organs.

- Receipt of cytotoxic chemotherapy within 3 months prior to enrollment.

- Prior radiation therapy to pelvis such that the proposed study treatment volume received 10 Gy or greater.

- Co-morbid severe concurrent disease that would result in a life expectancy of < 5 years.

- Diabetes mellitus-associated vascular ulcers or wounding healing problems, inflammatory bowel disease, or a diagnosed connective tissue disorder.

- Medical or psychiatric conditions that preclude informed decision-making or adherence to study protocols.

- Men of childbearing potential who are unwilling to employ adequate contraception.

Eligibility last updated 4/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Stish, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20545225

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