NCT02064036

Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate

Whole-Pelvic Radiotherapy With a Stereotactic Body Radiotherapy Boost and Long-Term Androgen Deprivation for Unfavorable-Intermediate and High Risk Localized Adenocarcinoma of the Prostate.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer. Our primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.

Detailed description

The primary objective of this study is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer. The secondary objective is to assess biochemical control at 24 months following the experimental treatment strategy by the "Phoenix definition". Patients not meeting these prostate-specific antigen (PSA) criteria (Phoenix Definition) for failure who undergo salvage therapies (such as androgen deprivation therapy (ADT), radical prostatectomy or brachytherapy, or Cryosurgery) should also be declared as failures at the time a positive biopsy is obtained or salvage therapy is administered, whichever comes first. Another secondary objective is to assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events The third secondary objective is to assess prostate organ motion during hypofractionated radiotherapy. To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic transponder beacons.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgical Boost	Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance
DRUG	Casodex	Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy
DRUG	Leuprolide	Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy

Timeline

• Start date: 2013-06-06
• Primary completion: 2020-12-03
• Completion: 2021-10-29
• First posted: 2014-02-17
• Last updated: 2022-10-18

Locations

1 site across 1 country: United States