Trial Title:
Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.
NCT ID:
NCT05820633
Condition:
Prostate Cancer
Node; Prostate
Radiotherapy Side Effect
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
ultra hypo fractionation
brachytherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized phase 3 study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)
Description:
Assess early and late genito-urinary (GU) toxicities induced assessed via the
International Prostate Symptom Score (I-PSS) in the experimental UHF group has compared
in a non-inferiority analysis to those of patients who received a standard treatment
(control group).
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Intervention type:
Radiation
Intervention name:
Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):
Description:
Assess early and late genito-urinary (GU) and gastro-intestinal (GI) toxicities induced
and quality of life assessed via expanded prostate cancer index composite (EPIC-26) in
the experimental UHF group has compared in a non-inferiority analysis to those of
patients who received a standard treatment (control group).
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Intervention type:
Radiation
Intervention name:
Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)
Description:
Assess early and late sexual health in the experimental UHF group has compared in a
non-inferiority analysis to those of patients who received a standard treatment (control
group).
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Intervention type:
Radiation
Intervention name:
Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)
Description:
Assess early and late toxicities reported according to the Common Terminology Criteria
for Adverse Events (CTCAE) in the experimental UHF group has compared in a
non-inferiority analysis to those of patients who received a standard treatment (control
group).
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Intervention type:
Radiation
Intervention name:
Report and compare the biochemical disease free survival (bDFS)
Description:
Assess the 5 and 10 years biochemical disease-free survival (bDFS) in the UHF group and
compare them for non-inferiority to those of the control group.
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Intervention type:
Radiation
Intervention name:
Report and compare the disease free survival (DFS)
Description:
Assess the 5 and 10 years disease-free survival (DFS) in the UHF group and compare them
for non-inferiority to those of the control group.
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Intervention type:
Radiation
Intervention name:
Report and compare the metastase free survival (MFS)
Description:
Assess the 5 and 10 years metastasis-free survival (MFS) in the UHF group and compare
them for non-inferiority to those of the control group.
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Intervention type:
Radiation
Intervention name:
Report and compare the overall survival (OS)
Description:
Assess the 5 and 10 years overall survival (OS) in the UHF group and compare them for
non-inferiority to those of the control group.
Arm group label:
standard of care fractionation (SOC)
Arm group label:
ultra hypo fractionation radiation therapy (UHF)
Summary:
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.
Detailed description:
Prostate cancer is the most common non-skin cancer in North American men. In 2020, an
estimated 23 300 Canadian men will be diagnosed with prostate cancer of which, 4200 will
die. Fortunately, with an early screening, most will have a localized disease at
diagnosis. Despite this, high risk disease affects a growing portion of the population
and this according to age (29.3%, 39.1%, 60.4%, et 90.6% respectively at 55-59, 65-69,
75-79, & 85-89 years of age). Gleason score 8 to 10 tumors follow the same pattern
(16.5%, 23.4%, 37.2%, and 59.9% at respective ages). Those patients are at risk for
harboring lymph nodes metastasis.
Multiple therapeutic options, with similar biochemical disease-free survival (bDFS) are
available: surgery +/- salvage radiotherapy +/- androgen deprivation therapy (ADT) or
radiotherapy (RT) +/- HDR-BT +/- ADT. For men with high-risk disease, the combined
approach of RT + HDR-BT + ADT might even offer higher cancer specific survival (CSS)
rates when compared to surgery.
HDR-BT allows for the delivery of a very high (ablative) dose of radiation while giving a
lower dose to the nearby organs at risk (OARs). Recently published literature showed that
pelvic RT plus HDR-BT significantly increased bDFS (84 vs 77%).
Pelvic RT is generally given on a daily basis (5 days/week) over a period of 4-5 weeks,
with 1,8-2,15Gy per fraction. This requires a substantial time investment from patients
undergoing treatment. Many studies have shown that prostate cancer offers a radiation
cell kill ratio (α/β) of 0.9-1.5 Gy. Furthermore, the most commonly used α/β value for
prostate cancer is 1,5 Gy (range 0,8 - 2,2). This low α/β ratio offers a more efficient
cell kill with hypo-fractionated doses, offering a better tumor control with a lower
cumulative dose, given in a shorter time span. Recently, a multicentric randomized phase
III study has shown similar late toxicity and oncologic control outcomes between UHF (>/=
5 Gy/fraction) and conventionally fractionated RT. However, until now, no phase III study
has compared combined UHF pelvic RT to standard fractionation combined with an HDR-BT in
this population.
The proposed experimental fractionation scheme for whole pelvic RT in this study will be
5Gy administered every other day over 2 weeks (UHF). It will be compared to standard
pelvic RT (1.8-2.15Gy/working day) given over 4 to 5 weeks. Both will be combined with a
single 15 Gy fraction of HDR-BT and ADT (goserelin). The UHF treatment modality
significantly reduces the overall treatment time, freeing machine-time and allowing more
patients to be treated. Given its low α/β ratio, prostate cancer is readily amenable to
UHF fractionation. The bio-equivalent dose calculations were done based on published
litterature. Neo-adjuvant and adjuvant ADT (goserelin) will be administered for a
duration according to NCCN guidelines.
In these COVID-19 pandemic times, a reduction in the number of patients' visits to the
clinic is highly desirable in order to limit the risk of virus transmission. UHF would
also lower the socio-economic burden incurred by the patients and their families. It also
increases the therapeutic efficiency reducing costs for both, patients and health
services. The proposed study aims to demonstrate the non-inferiority of UHF treatment
compared to standard of care. If this hypothesis is confirmed, all future patients could
benefit from it.
In order to improve the quality of life of men diagnosed with prostate cancer this study
aim to demonstrate that combined UHF pelvic RT plus HDR-BT (+ ADT according to NCCN
guidelines) is safe and non-inferior to standard fractionation regimens in regard to
toxicities and tumor control for prostate cancer patients with risk of nodal involvement.
Therefore, 500 men will be recruited, in order to confirm the hypothesis.
Criteria for eligibility:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
95 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
BC Cancer Sindi Ahluwalia centre for the Southern Interior
Address:
City:
Kelowna
Zip:
V1Y 5L3
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Juanita M Crook, MD, FRCPC
Phone:
250-712-3979
Email:
JCrook@bccancer.bc.ca
Facility:
Name:
Carlo Fidani Peel Regional Cancer Centre
Address:
City:
Mississauga
Zip:
L5M 2N1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Sarah Rauth, MD,FRCPC
Phone:
905-813-1100
Phone ext:
4803
Email:
srauth@cvh.on.ca
Facility:
Name:
Lakeridge Health Oshawa Cancer centre
Address:
City:
Oshawa
Zip:
L1G 2B9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Wayne Koll, MD, FRCPC
Phone:
905-576-8711
Facility:
Name:
CISSS de l'Outaouais, Hôpital de Gatineau
Address:
City:
Gatineau
Zip:
J8P 7H2
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Steven Tisseverasinghe, MD, FRCPC
Phone:
819-966-6100
Email:
steven.tisseverasinghe.med@ssss.gouv.qc.ca
Facility:
Name:
CISSS de Laval, Hôpital de la Cité-de-la-Santé
Address:
City:
Laval
Zip:
H7M 3L9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Danny Duplan, MD, FRCPC
Phone:
450-668-1010
Email:
danny.duplan.med@ssss.gouv.qc.ca
Facility:
Name:
CISSS de la Montérégie-Centre, Hôpital Charles-Le Moyne
Address:
City:
Longueuil
Zip:
J4V 2H1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Marjory Jolicoeur, MD, FRCPC
Phone:
450-466-5650
Email:
marjory.jolicoeur@umontreal.ca
Facility:
Name:
CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont
Address:
City:
Montréal-Est
Zip:
H1T 2M4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Peter Vavassis, MD, FRCPC
Phone:
514-252-3425
Email:
pvavassis.hmr@ssss.gouv.qc.ca
Facility:
Name:
CIUSSS du Centre-Ouest-de-l'Île-de-Montréal, Jewish General Hospital
Address:
City:
Montréal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Tamim Niazi, MDCM
Phone:
514-340-8288
Email:
tamim.niazi.med@ssss.gouv.qc.ca
Facility:
Name:
Cedars Cancer Centre, McGill University Health Centre (MUHC)
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Marie Duclos, MD
Phone:
514-934-4400
Email:
marie.duclos@mcgill.ca
Facility:
Name:
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Address:
City:
Sherbrooke
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Annie Ebacher, MD
Phone:
819-821-8000 ext. 74601
Email:
annie.ebacher.med@ssss.gouv.qc.ca
Facility:
Name:
CHU de Québec - Université Laval
Address:
City:
Quebec
Zip:
G1R 2J6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Andre-Guy Martin, MD,MSc,FRCPC
Phone:
1-418-691-5264
Email:
Andre-Guy.Martin.med@ssss.gouv.qc.ca
Contact backup:
Last name:
Josée Allard, MSc
Phone:
1-418-691-5264
Phone ext:
16730
Email:
Josee.Allard@chudequebec.ca
Investigator:
Last name:
Andre-Guy Martin, MD,MSc,FRCPC
Email:
Principal Investigator
Start date:
September 1, 2022
Completion date:
December 2035
Lead sponsor:
Agency:
CHU de Quebec-Universite Laval
Agency class:
Other
Collaborator:
Agency:
TerSera Therapeutics LLC
Agency class:
Industry
Source:
CHU de Quebec-Universite Laval
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05820633
https://www.cancer.ca/fr-ca/cancer-information/cancer-type/prostate/statistics
