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Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial


Inclusion Criteria:



- diagnosis of prostate adenocarcinoma and

- have had a prostatectomy

- have detectable PSA

- 18 years of age or older

Exclusion Criteria:

- are receiving chemotherapy or other agents intended for cancer treatment

- history of rectal surgery or lower gastrointestinal bleed

- history of bleeding diathesis or abnormal sensitivity to ionizing radiation

- had prior pelvic irradiation or are scheduled to receive pelvic nodal irradiation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity

Outcome Description:

Incidence of GU (genitourinary) and GI (gastrointestinal) toxicities of CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater

Outcome Time Frame:

over a period of 2 years

Safety Issue:

Yes

Principal Investigator

Timothy Showalter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

16604

NCT ID:

NCT01868386

Start Date:

April 2013

Completion Date:

December 2016

Related Keywords:

  • Prostate Cancer
  • Radiotherapy, hypofractionated
  • Salvage therapy
  • Radiotherapy, adjuvant
  • Prostatic Neoplasms

Name

Location

University of Virginia Health SystemCharlottesville, Virginia  22903