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A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate


Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Male
Prostatic Neoplasms

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Trial Information

A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

at each post treatment follow-up for up to 3 years

Safety Issue:

Yes

Principal Investigator

Charles Catton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 01-0181-C

NCT ID:

NCT00188513

Start Date:

May 2001

Completion Date:

May 2015

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

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