Clinical trial NCT00188513: Intensity Modulated Radiation Therapy - Prostate Cancer
Official title: A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 267
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are several different treatment schedules being used across the world for treatment of prostate cancer with radiation therapy. In order to determine the best radiation treatment for this disease, a study is being performed by the doctors at the Princess Margaret Hospital. This study will try to measure the effectiveness and side effects of an increased dose of radiation to the prostate that is also given over a shorter number of weeks than is usually done. In order to try to reduce the possible side effects of the radiation therapy the treatment will be given using special techniques to shield as much of your normal body tissues as possible. This method of treatment is called conformal intensity modulated radiation therapy, or IMRT.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate within six months of entry
* Clinical stage T1B, T1C, T2A-C NX MO (see Appendix 1 for staging). Any Gleason score is eligible for entry, but Gleason score must be determined.
* Patients with a PSA \>10.0 and Gleason score of 7; or patients with any PSA value and Gleason score of \>8 must have clinically negative lymph nodes as determined by a pelvic CT scan done within 12 weeks of entry. A negative bone scan is required before entry for all patients with Gleason score \>8, or any patient with a Gleason score of 7, and a PSA \>10.
* The patient must not have received any cytotoxic anticancer therapy. Previous or concurrent hormonal therapy for local disease is acceptable.
* ECOG performance status of 1 or less
* Age 80 years old or less
* Serum PSA \<25 ng/ml within 4 weeks of study entry
* Informed consent

Exclusion Criteria:

* Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
* Patients with prior colorectal surgery
* Any prior pelvic radiotherapy. Any prior TURP done \<12 weeks from study entry.
* Any previous cytotoxic chemotherapy
* Patients with prior malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer

Primary outcomes:
measure: To determine feasibility and late toxicity of administering 66 Gy in 22 fractions over 4.5 weeks (using conformal IMRT treatment techniques) to the prostate and adjacent tissues in patients with localized prostate ca
timeFrame: at each post treatment follow-up for up to 3 years
Secondary outcomes:
measure: To evaluate acute toxicity of therapy
timeFrame: weekly during RT
measure: To evaluate local control as assessed by prostate biopsy at 2.5 years
timeFrame: 2.5 years
measure: To evaluate time to disease progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Charles Catton, MD
role: PRINCIPAL_INVESTIGATOR
References: