Prostate CancerPhase 2NCT07291557
PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer
A Phase 2 study testing Prostate Only Radiation Therapy (PORT) and Prostate + Whole Pelvis Radiation Therapy (P-WPRT) in people with Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Only Radiation Therapy (PORT) and Prostate + Whole Pelvis Radiation Therapy (P-WPRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2026to May 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSMA-N0M0 patients who have a documented history of High Risk localized adenocarcinoma of the prostate are eligible to participate if they meet the following eligibility criteria:
- Participants capable of giving written informed consent.
- Male.
- Age ≥18 years.
- ECOG ≤2.
- Patient has histologically proven adenocarcinoma of prostate gland with an assigned Gleason score and Gleason Grade Group.
Show all 12Show fewer
- ≥NCCN High-Risk localized disease as per standard imaging investigations including pelvic imaging (CT, MRI) and 99Tc bone scan. High Risk prostate cancer defined as any of the following: cT3-T4 disease OR PSA ≥20 ng/ml OR Gleason grade group 4 or 5.
- No documentation of regional nodal (N1) or metastatic (M1) prostate cancer on standard imaging (CT, MRI, or 99Tc bone scan).
- In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate.
- Patient commits to androgen suppression treatment as per standard of care. 10. Patient is willing to complete symptom and patient reported outcome questionnaires.
- 11. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of radiation therapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
- Male patients should agree to not donate sperm during the study and for 6 months after completion of radiation therapy.
Who cannot join
- 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.
- History of prostatectomy or previous pelvic radiotherapy.
- Previous malignancy within the last five years, except BCC or SCC skin or a malignancy treated curatively with no evidence of disease for ≥5 years.
- Bilateral hip prostheses will be ineligible for study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PSMA-PET Directed Radiation Therapy in High and Very High-Risk Prostate Cancer
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.
Read the detailed description
The current treatment of high risk and very high risk localized prostate cancer is by radiation therapy (RT) and hormone therapy (ADT). RT uses radiation to kill the cancer cells while hormone therapy lowers the levels of male hormones like testosterone, which the cancer needs to grow. Radiation is targeted to the prostate and nearby tissues, which may or may not include whole pelvis radiation therapy (WPRT). The benefit of whole pelvis radiation therapy is not well understood. Therefore, clinical research is needed to assess the benefits/risks of whole pelvis radiation therapy in prostate cancer treatment. In addition to traditional cancer imaging methods like CT, MRI, and bone scan, new techniques like PSMA imaging are now available to examine prostate cancer. The PSMA scan involves a small amount of radioactive tracer (18F-PSMA-1007) being injected into the vein, which marks the prostate cancer cells for better visualization of the cancer location and spread. Because of its higher accuracy, results of PSMA scans can change how doctors plan cancer treatment, like where they aim radiation and how much they use.
In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.
There will be two treatment groups (1) Prostate Only Radiation Therapy (PORT), and Prostate + Whole Pelvis Radiation Therapy (P-WPRT), and all participants will receive hormone therapy as part of standard of care. In addition to comparing the biochemical failure free survival (BFFS) between the two treatment groups, the study will also compare distant metastases free survival (DMFS), toxicity, patient reported outcomes and overall survival (OS).
- Conditions
- Prostate Cancer
- Being tested
- Prostate Only Radiation Therapy (PORT), Prostate + Whole Pelvis Radiation Therapy (P-WPRT)
- Keywords
- Radiotherapy, PSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Only Radiation Therapy (PORT)Radiation
6800cGy in 25 daily fractions to the prostate and surrounding tissues
Prostate + Whole Pelvis Radiation Therapy (P-WPRT)Radiation
6800cGy to the prostate and surrounding tissues + 5000cGy to the whole pelvis in 25 daily fractions.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Only Radiation Therapy (PORT) | Active comparator | Radiation therapy: prostate and surrounding tissues Receives: Radiation: Prostate Only Radiation Therapy (PORT) |
| Prostate + Whole Pelvis Radiation Therapy (P-WPRT) | Experimental | Radiation therapy: prostate and surrounding tissues + whole pelvis radiation therapy Receives: Radiation: Prostate + Whole Pelvis Radiation Therapy (P-WPRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Number of events as measured from the date of randomization to 5-years.
Secondary outcomes (6)
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.
Measured: 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)
Acute and late toxicity as per CTCAE 5.0
Patient toxicity will be documented as per the domains of the CTCAE v5.0.
Measured: 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.
Overall survival
As measured form the time of randomization to the time of death from any cause.
Measured: As measured form the time of randomization to date of death from any cause, assessed up to 10 years (end of extended follow-up)
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
Measured: 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.
Patient reported outcomes: EQ-5D
The 5-item EQ-5D index score will be transformed into a utility score between 0, "Worst health state," and 1, "Best health state." The index score or the cost-utility equation can be used in the quality adjusted survival analysis. For this study, the plan is to report the multidimensional utilities for comparative purposes.
Measured: 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.
Patient reported outcomes: EPIC-26
Expanded Prostate Cancer Index Composite - Short Form (EPIC-26) uses a 0-100 scale per domain, where 0 means worst function and 100 means best function. EPIC-26 overall score will be reported, as well as intra-individual change from baseline. Score changes will also be stratified by clinically minimally important differences of 5 for bowel and hormonal, 7 for urinary, and 10 for sexual domain
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startDec 2026 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionMay 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291557
- Sponsor's protocol ID
- IIT-0031
- Status last verified
- Nov 2026
- First submitted
- 25 Nov 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-PET Directed Radiation Therapy in High and Very High-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT07291557
- Acronym / sponsor ID
- IIT-0031
- Conditions
- Prostate Cancer
- Keywords
- Radiotherapy, PSMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2036 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current treatment of high risk and very high risk localized prostate cancer is by radiation therapy (RT) and hormone therapy (ADT). RT uses radiation to kill the cancer cells while hormone therapy lowers the levels of male hormones like testosterone, which the cancer needs to grow. Radiation is targeted to the prostate and nearby tissues, which may or may not include whole pelvis radiation therapy (WPRT). The benefit of whole pelvis radiation therapy is not well understood. Therefore, clinical research is needed to assess the benefits/risks of whole pelvis radiation therapy in prostate cancer treatment. In addition to traditional cancer imaging methods like CT, MRI, and bone scan, new techniques like PSMA imaging are now available to examine prostate cancer. The PSMA scan involves a small amount of radioactive tracer (18F-PSMA-1007) being injected into the vein, which marks the prostate cancer cells for better visualization of the cancer location and spread. Because of its higher accuracy, results of PSMA scans can change how doctors plan cancer treatment, like where they aim radiation and how much they use.
In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy. PSMA imaging will be used to visualize prostate cancer prior to starting the trial.
There will be two treatment groups (1) Prostate Only Radiation Therapy (PORT), and Prostate + Whole Pelvis Radiation Therapy (P-WPRT), and all participants will receive hormone therapy as part of standard of care. In addition to comparing the biochemical failure free survival (BFFS) between the two treatment groups, the study will also compare distant metastases free survival (DMFS), toxicity, patient reported outcomes and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate Only Radiation Therapy (PORT) | Active comparator | Radiation: Prostate Only Radiation Therapy (PORT)Radiation therapy: prostate and surrounding tissues |
| Prostate + Whole Pelvis Radiation Therapy (P-WPRT) | Experimental | Radiation: Prostate + Whole Pelvis Radiation Therapy (P-WPRT)Radiation therapy: prostate and surrounding tissues + whole pelvis radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- PSMA-N0M0 patients who have a documented history of High Risk localized adenocarcinoma of the prostate are eligible to participate if they meet the following eligibility criteria:
- Participants capable of giving written informed consent.
- Male.
- Age ≥18 years.
- ECOG ≤2.
Key exclusion criteria (7 listed)
- 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.
- History of prostatectomy or previous pelvic radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate Only Radiation Therapy (PORT)6800cGy in 25 daily fractions to the prostate and surrounding tissues | Radiation | Prostate Only Radiation Therapy (PORT) |
| Prostate + Whole Pelvis Radiation Therapy (P-WPRT)6800cGy to the prostate and surrounding tissues + 5000cGy to the whole pelvis in 25 daily fractions. | Radiation | Prostate + Whole Pelvis Radiation Therapy (P-WPRT) |
Primary outcome
5-year Biochemical Failure Free Survival (BFFS)
Time frame: Number of events as measured from the date of randomization to 5-years.
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.
6 secondary outcomes
Distant metastases-free survival (DMFS)
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)
Acute and late toxicity as per CTCAE 5.0
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.
Overall survival
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)
Patient reported outcomes: IPSS
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.
Patient reported outcomes: EQ-5D
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.
Patient reported outcomes: EPIC-26
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate Only Radiation Therapy (PORT) and Prostate + Whole Pelvis Radiation Therapy (P-WPRT) in people with Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Rowe, MD (780-432-8966, Lindsay.rowe@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year Biochemical Failure Free Survival (BFFS) (time frame: Number of events as measured from the date of randomization to 5-years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.