Phase I-II trial evaluating combined intensity-modulated radiotherapy and in situ gene therapy with or without hormonal therapy in treatment of prostate cancer-interim report on PSA response and biopsy data.

What Was Tested

Researchers studied Flutamide and Thymidine Kinase in this phase 2 clinical trial publication.

There is an evolving role for combining radiotherapy (RT) with gene therapy in the management of prostate cancer.

However, the clinical results of this combined approach are much needed.

The preliminary results addressing the safety of this Phase I-II study combining RT and gene therapy (adenovirus/herpes simplex virus-thymidine kinase gene/valacyclovir with or without hormonal therapy) in the treatment of prostate cancer have been previously reported.

Who Took Part

The age groups tagged for this paper are adults, middle-aged adults, older adults and people over 80, men only.

Arm A consisted of low-risk patients (Stage T1-T2a, Gleason score <7, pretreatment PSA <10 ng/mL) treated with combined RT-gene therapy.

Arm C consisted of patients with Stage D1 (positive pelvic lymph nodes) who received the same regimen as Arm B with the addition of 45 Gy to the pelvic lymphatics.

How the Study Was Run

This trial was composed of three separate arms.

They also received adenovirus/herpes simplex virus-thymidine kinase/valacyclovir gene therapy.

PSA determination and biopsy were performed before, during, and after treatment.

The American Society for Therapeutic Radiology and Oncology consensus definition (three consecutive rises in PSA level) was used to denote PSA failure.

What Was Measured

The subject headings attached to it are Acyclovir, Adenoviridae, Androgen Antagonists, Antineoplastic Agents, Hormonal, Antiviral Agents, Biopsy and Combined Modality Therapy.

What This Means in Plain Language

This is a phase 2 clinical trial of Flutamide and Thymidine Kinase.

Results are reported in around 18 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2004 (International journal of radiation oncology, biology, physics), a journal based in United States.

More context: all human trials.