PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer

NCT07291557 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IIT-0031
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Radiotherapy; PSMA

Outcome Measures

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.

  Number of events as measured from the date of randomization to 5-years.

Secondary Outcomes (6)

• Distant metastases-free survival (DMFS)

  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

  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 date of death from any cause, assessed up to 10 years (end of extended follow-up)

• Patient reported outcomes: IPSS

  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

  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 (4)

• 10-year Biochemical Failure Free Survival (BFFS)

  Retrospective chart reviews will occur during long term follow-up (years 5 to 10, inclusive).

• 10-year Disease Free Survival (DFS)

  Retrospective chart reviews will occur during long term follow-up (years 5 to 10, inclusive).

• 10-year Distant Metastases-Free Survival (DMFS)

  Retrospective chart reviews will occur during long term follow-up (years 5 to 10, inclusive).

Study Arms (2)

Prostate Only Radiation Therapy (PORT)

ACTIVE COMPARATOR

Radiation therapy: prostate and surrounding tissues

Radiation: Prostate Only Radiation Therapy (PORT)

Prostate + Whole Pelvis Radiation Therapy (P-WPRT)

EXPERIMENTAL

Radiation therapy: prostate and surrounding tissues + whole pelvis radiation therapy

Radiation: Prostate + Whole Pelvis Radiation Therapy (P-WPRT)

Interventions

Prostate Only Radiation Therapy (PORT) RADIATION

6800cGy in 25 daily fractions to the prostate and surrounding tissues

Prostate Only Radiation Therapy (PORT)

Prostate + Whole Pelvis Radiation Therapy (P-WPRT) RADIATION

6800cGy to the prostate and surrounding tissues + 5000cGy to the whole pelvis in 25 daily fractions.

Prostate + Whole Pelvis Radiation Therapy (P-WPRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≥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.
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Lindsay Rowe, MD

CONTACT

780-432-8966; Lindsay.rowe@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 18, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2036
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)