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Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.

Prostate Cancer | Radiotherapy Side Effect | Node; Prostate

Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.

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Participation Requirements

  • Sex:

    MALE

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* Histopathologically confirmed adenocarcinoma of the prostate.
* All clinical stages with lymph node involvement risk needing pelvis RT.
* Stage Mx or M0.
* Unfavorable Intermediate, high or very high-risk disease according to NCCN guidelines.
* Having the ability to give free and informed consent.

Exclusion Criteria:

* Clinical stage M1.
* IPSS Score \> 20 with alpha-blocking medication.
* Prior pelvic radiotherapy,
* History of active collagenosis (Lupus, Scleroderma, Dermatomyositis).
* Past history of Inflammatory Bowell Disease.
* Bilateral hip prosthesis.

Study Location

Lakeridge Health Oshawa Cancer centre
Lakeridge Health Oshawa Cancer centre
Oshawa, Ontario
Canada

Contact Study Team

Primary Contact

Wayne Koll, MD, FRCPC

905-576-8711
CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont
CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont
Montréal-Est, Quebec
Canada

Contact Study Team

Primary Contact

Peter Vavassis, MD, FRCPC

[email protected]
514-252-3425
Carlo Fidani Peel Regional Cancer Centre
Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario
Canada

Contact Study Team

Primary Contact

Sarah Rauth, MD,FRCPC

[email protected]
905-813-1100
CISSS de la Montérégie-Centre, Hôpital Charles-Le Moyne
CISSS de la Montérégie-Centre, Hôpital Charles-Le Moyne
Longueuil, Quebec
Canada

Contact Study Team

Primary Contact

Marjory Jolicoeur, MD, FRCPC

[email protected]
450-466-5650
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec
Canada

Contact Study Team

Primary Contact

Annie Ebacher, MD

[email protected]
819-821-8000 ext. 74601
CISSS de l'Outaouais, Hôpital de Gatineau
CISSS de l'Outaouais, Hôpital de Gatineau
Gatineau, Quebec
Canada

Contact Study Team

Primary Contact

Steven Tisseverasinghe, MD, FRCPC

[email protected]
819-966-6100
CIUSSS du Centre-Ouest-de-l'Île-de-Montréal, Jewish General Hospital
CIUSSS du Centre-Ouest-de-l'Île-de-Montréal, Jewish General Hospital
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Tamim Niazi, MDCM

[email protected]
514-340-8288
BC Cancer Sindi Ahluwalia centre for the Southern Interior
BC Cancer Sindi Ahluwalia centre for the Southern Interior
Kelowna, British Columbia
Canada

Contact Study Team

Primary Contact

Juanita M Crook, MD, FRCPC

[email protected]
250-712-3979
CISSS de Laval, Hôpital de la Cité-de-la-Santé
CISSS de Laval, Hôpital de la Cité-de-la-Santé
Laval, Quebec
Canada

Contact Study Team

Primary Contact

Danny Duplan, MD, FRCPC

[email protected]
450-668-1010
Cedars Cancer Centre, McGill University Health Centre (MUHC)
Cedars Cancer Centre, McGill University Health Centre (MUHC)
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Marie Duclos, MD

[email protected]
514-934-4400
Study Sponsored By
CHU de Quebec-Universite Laval
Participants Required
More Information
Study ID: NCT05820633