Posted by on Jul 27, 2015 in Prostate cancer | 0 comments

In a nutshell

This phase I/II trial aims to determine the safety of administering shorter courses of radiation over a shorter period of time to patients who have had their prostate removed. The main outcome to be investigated is dose safety and toxicity in patients and to determine quality of life benefits. 

The details

Radiation therapy involves directing a beam of radiation at the tumor site in order to kill cancer cells with minimal damage to healthy cells. Hypofractionated radiation is a type of radiation therapy that involves receiving large, daily doses of radiation for a shorter period of time than standard radiation. The aim is to target cancer cells while minimizing the damage done to normal cells.

Some prostate cancer patients experience a rise in prostate specific antigen (PSA – protein elevated in the blood in the presence of prostate cancer) levels following surgical removal of the prostate. Radiation therapy is the standard treatment for these patients. This study will evaluate the efficacy of a shorter course of radiation by looking at the side effects experienced by patients and the effect of treatment on tumor growth.

Who are they looking for?

This study is recruiting 52 men in Virginia, United States over the age of 18 years who have been diagnosed with adenocarcinoma and have undergone prostate surgery to remove the prostate gland. Patients must have detectable PSA levels .

Patients cannot take part in this trial if they are currently receiving chemotherapy or other cancer treatments. Candidates who have a history of rectal surgery, lower stomach and intestine bleeding, sensitivity to radiation or candidates who have previously received or are currently scheduled to receive pelvic radiation will not be considered for this trial.

How will it work

Patients will be given four doses of radiation to determine dosage safety and side effects. Dose level 1 will involve 26 treatments at 2.5 Gy. Dose level 2 will involve 20 treatments at 2.83 Gy. Dose level 3 will involve 15 treatments at 3.36Gy and Dose level 4 will involve 10 treatments at 4.26 Gy. 

Patients will be followed for up to 2 years. The rate of dose-limiting toxicities (side effects that limit the use of the treatment), patient quality of life, and rate of recurrence (measured by a rise in PSA levels) will be measured.

Clinical trial locations

Locations near 20147, United States (Change):
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Study ID:NCT01868386
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