Phase I/II trial evaluating combined radiotherapy and in situ gene therapy with or without hormonal therapy in the treatment of prostate cancer--a preliminary report.

What Was Tested

This phase 2 clinical trial looks at Leuprolide and Flutamide.

To report the preliminary results of a Phase I/II study combining radiotherapy and in situ gene therapy (adenovirus/herpes simplex virus thymidine kinase gene/valacyclovir) with or without hormonal therapy in the treatment of prostate cancer.

Who Took Part

By PubMed's age tags, the people studied were adults, middle-aged adults, older adults and people over 80, men only.

Arm A: low-risk patients (T1-T2a, Gleason score <7, pretreatment PSA <10) were treated with combined radio-gene therapy.

Arm B: high-risk patients (T2b-T3, Gleason score >or=7, pretreatment PSA >or=10) were treated with combined radio-gene therapy and hormonal therapy.

How the Study Was Run

Hormonal therapy was comprised of a 4-month leuprolide injection and 2-week use of flutamide.

Arm C: Stage D1 (positive pelvic lymph node) patients received the same regimen as Arm B, with the additional 45 Gy to the pelvic lymphatics.

Treatment-related toxicity was assessed using Cancer Therapy Evaluation Program common toxicity score and Radiation Therapy Oncology Group (RTOG) toxicity score.

What Was Measured

PubMed files the paper under topics including Adenoviridae, Combined Modality Therapy, Flutamide, Genetic Therapy, Genetic Vectors, Leuprolide and Lymphatic Irradiation.

What This Means in Plain Language

This is a phase 2 clinical trial of Leuprolide and Flutamide.

The abstract goes on to report its results in about 16 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2001 (International journal of radiation oncology, biology, physics), a journal based in United States.

More context: the related Leuprolide library page, all human trials.