Prostate cancer study of CRT + Upfront ADT vs. PHPC + Salvage ADT

Titre officiel

A Randomized Phase II Study of the Clinical and Metabolic Effects Of Conventional RT with Upfront ADT vs Escalated Dose Hypofractionated RT With Prompt ADT Salvage in High-Risk Prostate Cancer

Sommaire:

L’étude proposée a pour but d’examiner les répercussions cliniques et métaboliques de l’utilisation de la radiothérapie hypofractionnée à doses croissantes avec une suppression androgénique de rattrapage comparativement au recours dès le départ à la suppression androgénique avec la radiothérapie classique.

Critères d’évaluation primaires :

• Développement d’un cancer de la prostate réfractaire à l’hormonothérapie.
• Changements dans les paramètres métaboliques et la composition corporelle.

Critères d’évaluation secondaires :

• Récidive biochimique.
• Survie globale.
• Effets toxiques du rayonnement.

Description de l'essai

Patients with high risk prostate cancer will be randomized to receive either conventional therapy (conventional RT + upfront ADT) or the investigational therapy (hypofractionated RT + prompt ADT salvage). Patients will be evaluated for acute radiation treatment related toxicities at each visit throughout the treatment period as well as at 6 weeks following the end of treatment.

Patients will continue to be followed at the Cancer Centre in accordance with standard clinical practice as follows:

• PSA testing conducted every 3 months thereafter for 5 years
• Follow-up visits in the clinic at 6 months following the 6 week post end of treatment visit and every 6 months thereafter until 5 years from the start of treatment.

In addition, metabolic evaluations will be conducted at the University of Waterloo at the end of treatment and at 6 months following the 6 week post end of treatment visit.