Trial Title:
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment
NCT ID:
NCT06235697
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Androgens
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiation
Description:
46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate
- Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24
months
Arm group label:
EBRT + Brachy Boost
Intervention type:
Radiation
Intervention name:
Radiation SBRT only
Description:
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT)
Arm group label:
SBRT
Intervention type:
Drug
Intervention name:
ADT
Description:
Assigned at enrollment
Arm group label:
EBRT + Brachy Boost
Other name:
Androgen Deprivation Therapy
Summary:
This study is being done to answer the following question: Is the strategy to give higher
doses of radiotherapy treatment over a shorter period of time using special equipment and
fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective
as usual external radiation therapy given with a brachytherapy boost (which involves
radiation sources inserted directly into the prostate)?
Detailed description:
The usual approach for patients with unfavourable prostate cancer who are not in a study
is treatment with external beam radiation therapy (EBRT) to the pelvis and prostate in
combination with hormone therapy (androgen deprivation therapy - ADT). To improve control
of prostate cancer at risk of returning, additional treatment with a brachytherapy boost
(insertion of radiation sources directly into the prostate) is recommended. For patients
who get the usual approach for this cancer, about 89 out of 100 are free of cancer after
5 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9
months
- Participants with unfavourable risk prostate cancer are eligible according to the
following NCCN classification guidelines (Version 4.2022 - May 10, 2022):
• Unfavourable-intermediate risk - has one or more of the following:
- 2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3),
and/or PSA 10-20 ng/ml;
- Gleason 4+3 (grade group 3)
- > 50% biopsy cores positive
• High risk - has one of the following:
- cT3a
- Gleason 8-10 (grade group 4 or 5)
- PSA > 20 ng/ml
• Very-high risk - has at least one of the following:
- cT3b-cT4
- Primary Gleason pattern 5
- 2 or 3 high risk features: cT3a, Gleason 8-10 (grade group 4 or 5), and/or PSA > 20
ng/ml
- > 4 cores with Gleason 8-10 (grade group 4 or 5)
- ECOG performance status of 0, 1 or 2
- Participants must be ≥ 18 years of age
- Judged to be medically fit for brachytherapy
- Participant is able (i.e. sufficiently fluent) and willing to complete the quality
of life and/or health utility questionnaires in either English, French or Spanish
- Participants consent must be appropriately obtained in accordance with applicable
local and regulatory requirements. Each participant must sign a consent form prior
to enrollment in the trial to document their willingness to participate
- Participants must be accessible for treatment and follow-up. Investigators must
assure themselves the participants enrolled on this trial will be available for
complete documentation of the treatment, adverse events, and follow-up
- In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of
participant enrollment
- Participants must be willing to take precautions to prevent pregnancy while on study
- ADT (LHRH agonists, antagonists, or anti-androgens) for prostate cancer is permitted
for up to 30 days before study enrollment
- 5-alpha reductase inhibitors (5-ARI) are allowed, but baseline PSA will be corrected
if 5-ARI use occurs within 6 months of enrollment
- Participants may NOT have received other therapies including chemotherapy, PARPi,
radioligand or other investigational drugs for prostate cancer
- Participants with a prior or concurrent malignancy whose natural history or
treatment does not have the potential to interfere with the safety or efficacy
assessment of the investigational regimen are eligible for this trial
- Urinary function defined as International Prostate Symptom Score (IPSS) < 20. Alpha
blockers are allowed to treat baseline urinary function
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral
load within 6 months are eligible for this trial
Exclusion Criteria:
- Prior pelvic radiotherapy
- Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or
inflammatory bowel disease)
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion or
brachytherapy implant) and/or prior or current bleeding diathesis
- Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP),
prostatectomy (simple or radical), or any ablative therapy to the prostate
(cryotherapy, HIFU, TULSA, focal laser ablation, photodynamic therapy)
- Prostate volume > 60cc before start of androgen deprivation therapy
- Anatomy that would preclude precise brachytherapy implant (such as arch interference
or large median lobe)
- Evidence of castrate resistance (defined as a rising PSA > 3.0 ng/ml while
testosterone is < 3.0 nmol/l)
- Hip prosthesis
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Siteman Cancer Center at West County Hospital
Address:
City:
Creve Coeur
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Lannis E. Hall
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Lannis E. Hall
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center-South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Lannis E. Hall
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Christian Hospital
Address:
City:
Saint Louis
Zip:
63136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Lannis E. Hall
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Saint Peters Hospital
Address:
City:
Saint Peters
Zip:
63376
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Lannis E. Hall
Email:
Principal Investigator
Facility:
Name:
Trillium Health Partners - Credit Valley Hospital
Address:
City:
Mississauga
Zip:
L5M 2N1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
905-813-4040
Investigator:
Last name:
Jasper Yuen
Email:
Principal Investigator
Facility:
Name:
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
416-480-5000
Investigator:
Last name:
Douglas Andrew B. Loblaw
Email:
Principal Investigator
Facility:
Name:
University Health Network-Princess Margaret Hospital
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
416-946-4501
Email:
clinical.trials@uhn.on.ca
Investigator:
Last name:
Rachel M. Glicksman
Email:
Principal Investigator
Start date:
April 25, 2024
Completion date:
April 30, 2033
Lead sponsor:
Agency:
Canadian Cancer Trials Group
Agency class:
Other
Collaborator:
Agency:
NRG Oncology
Agency class:
Other
Source:
Canadian Cancer Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06235697
