PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorAHS Cancer Control Alberta
About this trial
In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy targeted to the prostate and nearby tissues with or without whole pelvis radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants capable of giving written informed consent.
Male.
Age ≥18 years.
ECOG ≤2.
Disqualifiers
Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance, interpretation, or compliance with radiation
Patients who have initiated therapy (ADT, systemic therapy, or radiation) for their prostate cancer prior to PSMA-PET imaging.
History of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Prostate Only Radiation Therapy (PORT)
Radiation6800cGy in 25 daily fractions to the prostate and surrounding tissues
Prostate + Whole Pelvis Radiation Therapy (P-WPRT)
Radiation6800cGy to the prostate and surrounding tissues + 5000cGy to the whole pelvis in 25 daily fractions.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Prostate Only Radiation Therapy (PORT)Active comparator 1 intervention
Group B: Prostate + Whole Pelvis Radiation Therapy (P-WPRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
5-year Biochemical Failure Free Survival (BFFS)
As measured from the date of randomization to the first recorded date of biochemical failure as defined by serum PSA exceeding nadir PSA +2 ng/mL.
Time frame
Number of events as measured from the date of randomization to 5-years.Secondary outcomes
1
Distant metastases-free survival (DMFS)
Calculated from the time of randomization until the development of first distant metastasis outside the pelvic nodal regions. Patients will be censored at either the date of last follow-up or date of death.
Time frame
As measured from the date of randomization until the development of first distant metastasis outside the pelvic nodal regions or date of death from any cause, whichever came first; assessed up to 10 years (end of extended follow-up)2
Acute and late toxicity as per CTCAE 5.0
Patient toxicity will be documented as per the domains of the CTCAE v5.0.
Time frame
Acute toxicity will be measured up to the 90 days post-radiation, and late toxicity will be monitored over the course of the study follow-up, up to 5 years post-radiation.3
Overall survival
As measured form the time of randomization to the time of death from any cause.
Time frame
As measured form the time of randomization to date of death from any cause, assessed up to 10 years (end of extended follow-up)4
Patient reported outcomes: IPSS
International Prostate Symptom Score (IPSS) is a standardized questionnaire used worldwide to assess the severity of urinary symptoms. It consists of 7 questions, each scored from 0 (no symptoms) to 5 (most severe symptoms). The total score is the sum of all responses, giving a range from 0 to 35
Time frame
Outcomes will be measured from the completion of radiation up to 90 days post-radiation, and over the course of the study follow-up, up to 5 years post-radiation.Other outcomes
1
10-year Biochemical Failure Free Survival (BFFS)
Patient charts will be reviewed retrospectively after patients have completed clinical trial follow-up for clinical history up to 10 years postradiation. BFFS will be calculated from the time of randomization to the date to PSA relapse
Time frame
Retrospective chart reviews will occur during long term follow-up (years 5 to 10, inclusive).2
10-year Disease Free Survival (DFS)
Patient charts will be reviewed retrospectively after patients have completed clinical trial follow-up for clinical history up to 10 years postradiation. DFS is calculated from the time of randomization to the first biochemical or clinicoradiological recurrence of disease at any site, or death due to any cause, whichever occurs earlier
Time frame
Retrospective chart reviews will occur during long term follow-up (years 5 to 10, inclusive).3
10-year Distant Metastases-Free Survival (DMFS)
Patient charts will be reviewed retrospectively after patients have completed clinical trial follow-up for clinical history up to 10 years postradiation. DMFS will be calculated from the time of randomization until the development of first distant metastasis outside the pelvic nodal regions.
Time frame
Retrospective chart reviews will occur during long term follow-up (years 5 to 10, inclusive).4
Assessment of fatigue over the course of therapy
Patient level of fatigue will be assessed as a patient reported outcome using the validated Brief Fatigue Inventory (BFI) which will be completed at each of the AE and quality of life assessments. BFI uses a 0-10 scale per item, with 0 meaning no fatigue and 10 meaning the worst fatigue. Longitudinal scores for each patient will be correlated with therapy received and radiation dosimetry.
Time frame
Outcomes will be measured from the completion of radiation up to 90 days post-radiation, and over the course of the study follow-up, up to 5 years post-radiation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AHS Cancer Control Alberta
Lead sponsor
Cross Cancer Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: