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Feasibility study fails to meet recruitment target for HDR brachytherapy vs SBRT in recurrent prostate cancerWhy is it so hard to recruit men for a second prostate cancer radiation study?

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Key Takeaway
Consider patient preference a major barrier when designing trials comparing reirradiation options for recurrent prostate cancer.

This was a 3-center randomized feasibility study investigating whether patients with locally recurrent prostate cancer following definitive radiotherapy could be recruited to a trial comparing high-dose-rate brachytherapy (HDR BT) versus stereotactic body radiotherapy (SBRT) for reirradiation. The primary outcome was recruitment feasibility, with a target of 60 participants over 24 months. Of 60 patients screened, 18 (30%) were ineligible. Of the 42 eligible patients, only 23 (54.8%) were randomized (13 to HDR BT, 10 to SBRT). Recruitment was uneven across centers, with one center recruiting only 2 patients. One randomized participant withdrew before starting treatment; other safety and tolerability data were not reported. Key limitations include the failure to meet the recruitment target and the identification of patient preference for a specific treatment as a major barrier. The study's practice relevance is limited to trial design, suggesting future studies should incorporate patient, clinician, or center preference for reirradiation options. This small study (n=23) provides no evidence on the comparative effectiveness or safety of HDR BT versus SBRT.

Imagine you've already had radiation for prostate cancer, and now it's come back. Doctors want to know the best way to deliver a second, targeted dose of radiation, but they need a fair comparison. A new study tried to set up that comparison by randomly assigning men to one of two precise radiation techniques: high-dose-rate brachytherapy (where radioactive seeds are placed inside the prostate) or stereotactic body radiotherapy (a highly focused external beam).

The main finding wasn't about which treatment worked better, but whether such a study could even be done. The answer, for now, is that it's very challenging. The study aimed to recruit 60 men across three centers but only enrolled 23. A major reason was that men, when faced with this difficult decision, often had a strong preference for one type of radiation over the other and didn't want to leave it to chance.

This was a small, preliminary feasibility study. Its goal was to test the logistics of running a larger trial, not to compare the safety or effectiveness of the treatments. One participant withdrew before starting treatment, but no other safety data was reported. The key takeaway for researchers is clear: to learn what works best, future studies might need to let patients choose their preferred re-treatment method and then compare those results to the current standard of care, rather than asking them to accept a random assignment.

What this means for you:
Patient preference is a major barrier to studying second radiation treatments for recurrent prostate cancer.

Study Details

Study typeRct
Sample sizen = 13
EvidenceLevel 2
Follow-up24.0 mo
PublishedApr 2026
View Original Abstract ↓
AIMS: Prostate cancer which recurs within the prostate following definitive radiotherapy can be treated again using radiation, known as reirradiation. Systematic reviews of cohort studies of salvage therapies suggest that reirradiation using brachytherapy (BT) or stereotactic body radiotherapy (SBRT) offers favourable disease control with acceptable toxicity. However, the optimal radiotherapy modality in this setting remains to be determined. The study aimed to establish feasibility of randomisation between HDR BT and SBRT. MATERIALS AND METHODS: The reirradiation options for previously irradiated prostate cancer (RO-PIP) study is a randomised feasibility study of high-dose-rate BT (HDR BT) or SBRT for locally recurrent prostate cancer. The primary objective was to recruit 60 participants across three centres over a 24-month period. Secondary endpoints include other measures of feasibility, participant-reported outcomes, and clinician-reported acute and long-term toxicity. RESULTS: Between October 2022 and May 2025, 60 patients were screened and 18 (30%) were deemed ineligible. Of 42 eligible patients, 23 (54.8%) were randomised to HDR BT (n = 13) or SBRT (n = 10). One randomised participant withdrew prior to commencing treatment. One centre recruited 2 patients and the other centres recruited 9 and 12 patients, respectively. The most common reason for nonparticipation was treatment preference, with 10 patients preferring HDR BT (n = 7), SBRT (n = 2), or androgen deprivation therapy alone (n = 1). Six patients declined to participate for non-disclosed reasons. One patient declined participation due to distance from the treating site, 1 patient declined a biopsy, and 1 patient preferred observation. CONCLUSION: Planned recruitment targets to a randomised multicentre study of BT or SBRT for treatment of locally recurrent prostate cancer were not achieved. A major barrier to participation was patient preference for a specific treatment. Future studies should be designed to allow patient, clinician, and/or centre preference for reirradiation options (either BT or SBRT), which could then be compared to standard of care.
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