Timing of imaging after prostate cancer surgery
A Phase II Randomized Feasibility Study Comparing Early Salvage Radiotherapy Versus Surveillance With Delayed Repeat PSMA PET/CT Imaging in Patients Presenting With Early Biochemical Relapse of Prostate Cancer Following Radical Prostatectomy
PHASE2 · University Health Network, Toronto · NCT05008900
This study is testing whether starting radiation treatment right away or monitoring PSA levels first is better for men who have had prostate surgery and are seeing early signs of cancer returning.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05008900 on ClinicalTrials.gov |
What this trial studies
This study investigates the timing of PSMA imaging in patients who have undergone prostatectomy and are experiencing early biochemical recurrence (BCR) of prostate cancer. Patients will be randomized into two groups: one receiving upfront salvage radiotherapy (SRT) and the other undergoing surveillance with periodic PSA monitoring. If the PSA levels reach a certain threshold, a repeat PSMA PET/CT will be performed. The goal is to determine the most effective approach for managing early BCR in this patient population.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically-proven prostate cancer who have undergone radical prostatectomy and have a PSA level between 0.1 and 0.3 ng/mL post-surgery.
Not a fit: Patients who have received previous pelvic radiotherapy or are currently on androgen deprivation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with early biochemical recurrence of prostate cancer, potentially enhancing treatment outcomes.
How similar studies have performed: While there is ongoing research in this area, this specific approach to timing PSMA imaging in early BCR is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically-proven prostate cancer * pT1-T4 pN0/Nx cM0 * PSA at BCR \>0.1 - \<0.3 ng/mL post-radical prostatectomy * PSMA PET/CT negative at BCR post radical prostatectomy * Planned SRT to prostate bed +/- pelvic lymph nodes * ECOG 0 or 1 * Age ≥ 18 years * Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed. Exclusion Criteria: * Active or post prostatectomy androgen deprivation use * Previous pelvic radiotherapy * Other contraindications to radiotherapy
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Srinivas Raman, MD
- Email: srinivas.raman@rmp.uhn.ca
- Phone: 416-946-2320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Prostatectomy