FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiation Therapy for High Risk Prostate Cancer

Titre officiel

FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiation Therapy for High Risk Prostate Cancer

Sommaire:

Cette étude vise à examiner l’innocuité d’une radiothérapie de plus courte durée associée à une hormonothérapie androgénosuppressive d’une durée de un an. Ce traitement sera administré à des hommes qui présentent un risque élevé de cancer de la prostate et chez qui, en raison d’une autre maladie ou de circonstances particulières, la radiothérapie classique de longue durée et l’hormonothérapie ne sont pas recommandées par leur médecin ou désirées par le patient.

Description de l'essai

Primary Outcome:

• Toxicity
• Toxicity
• Toxicity

Secondary Outcome:

• Disease Free Survival
• Quality of Life

Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80Gy/7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant luteinizing hormone releasing hormone (LHRH) agonist) compared to a primary hormone therapy or radiation therapy alone in men with locally advanced/high risk disease. While this approach may be tolerable in fit individuals, this combination may not be well tolerated by frail individuals or those who live at a distance who may find it difficult to attend for 7 weeks of radiation due to travel considerations. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy. This pilot study will explore the combination of a stereotactic body radiation therapy (SBRT) approach (designed to be iso-effective for late effects for standard radiation therapy) combined with one year of LHRH agonist for older men with high risk disease who are less fit (Vulnerable Elderly Score > 3) or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

Voir cet essai sur ClinicalTrials.gov