Improving treatment for advanced prostate cancer using advanced imaging techniques

Optimizing the Management of High-risk and Unfavorable Intermediate-risk Disease: the Use of Advanced Imaging, Trans-perineal Mapping Biopsies, and Dual-strength Brachytherapy Sources to Minimize Radiation Dose to Normal Tissues

This study is testing a new way to treat men with advanced prostate cancer by using better imaging techniques to target the cancer more precisely and reduce side effects.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: British Columbia Cancer Agency (other)
• Drugs / interventions: radiation
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT03836196 on ClinicalTrials.gov

What this trial studies

The OPTiMAL trial aims to enhance treatment outcomes for men with locally advanced prostate cancer by integrating advanced imaging and biopsy techniques. This multi-modality approach combines low-dose-rate brachytherapy with external beam radiation therapy to precisely target cancer while minimizing damage to healthy tissue. The study builds on findings from the ASCENDE-RT trial, which demonstrated high cure rates but also significant side effects. By optimizing radiation delivery, the trial seeks to reduce adverse effects and improve quality of life for patients.

Who should consider this trial

Good fit: Ideal candidates include men with histologically-proven prostate cancer classified as high-risk or intermediate-risk with specific adverse features.

Not a fit: Patients with very high pre-intervention PSA levels or those who have undergone prior surgical treatments for prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better treatment outcomes with fewer side effects for patients with advanced prostate cancer.

How similar studies have performed: Previous studies, such as the ASCENDE-RT trial, have shown success with similar approaches, indicating potential for this novel methodology.

Eligibility criteria

Inclusion Criteria:

* Patients must have histologically-proven prostate cancer
* Patients must meet either: a. National Comprehensive Cancer Network (NCCN) definition of high-risk disease or b. Intermediate-risk disease with at least 3 points using the following scale: One point each for clinical stage = T2b-c, iPSA \>7 ng/mL, and Gleason grade group 2 (overall Gleason sum 3+4 =7), Two points for Gleason grade group 3 (overall Gleason sum 4+3 =7).
* Patients must have N0 M0 status on the basis of technetium bone scan and computed tomography (CT) scan of the pelvis

Exclusion Criteria:

* Those with pre-intervention prostate specific antigen (iPSA) above 100 ng/mL.
* Those who have received prior surgical treatment for prostate cancer including transurethral resection of the prostate (TURP), transurethral resection of the bladder neck (TURB), cryotherapy, laser ablation, or high frequency ultrasound (HIFU)
* Those with an estimated life expectancy of less than 5 years with an Eastern Cooperative Oncology Group (ECOG ) performance status above 0-2
* Those with prior radiation therapy to the pelvis.
* Those who have received androgen deprivation therapy (ADT) prior to registration.
* Contraindication to high-dose pelvic irradiation, Luteinizing hormone-releasing hormone (LHRH) agonists, or nonsteroidal antiandrogen therapy
* Those who are not able to participate in an MRI scan (i.e. significant renal impairment that would preclude the use of contrast agent, some patients with cardiac pacemaker, wires, or defibrillator; artificial heart valve; brain aneurysm clip; electrical stimulator for nerves or bones; ear or eye implant; implanted drug infusion pump; coil; catheter, or filter in any blood vessel. Some men with metallic prosthesis; shrapnel, bullets, or other metal fragments retained in the body)
* Those who are not able to participate in a PET/CT scan
* Cancer survivors who do not meet all three of the following criteria: a) The patient has undergone potentially curative therapy for all prior malignancies. b) There has been no evidence of recurrence for at least five years following potentially curative therapy. (For non-melanoma skin cancer the five-year requirement does not apply.) and c) The patient is considered by the treating physician to be at low risk of recurrence from prior malignancies.
* Those who are on anticoagulation therapy (blood thinners) and are unable stop this medication safely for at least 5 days.

Where this trial is running

Vancouver, British Columbia

• BC Cancer - Vancouver — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Michael Peacock, MD — BCCANCER
• Study coordinator: Michael Peacock, MD

Conditions: Prostate Cancer, PSMA PET/CT, multi-parametric MRI, multi-parametric TRUS, Transperineal mapping biopsy, LDR Brachytherapy, External Beam Radiation Treatment