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

NCT02064036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-10-18

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma of the Prostate

Interventions

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

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Richard Valicenti, MD · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-06
Primary Completion
2020-12-03
Completion
2021-10-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064036 on ClinicalTrials.gov