Barber, Jim

TPS7 Background: Penis cancer is a rare but potentially fatal disease. A limited body of evidence exists on which to base the majority of management decisions for patients with regional nodal metastases. Five-year survival for patients with a single involved inguinal lymph node treated with surgery alone is approximately 80%, whilst it ranges from 0 to 12% for patients with pelvic node involvement (N3). Additional strategies are required for the management regionally-advanced disease. InPACT (NCT02305654) aims to determine prospectively the relative benefits and sequencing of surgery, chemotherapy, and chemoradiotherapy in the management of patients with penis cancer who present with palpable or radiologically evident inguinal lymph node metastases. InPACT addresses the following questions: Is there a role for neoadjuvant therapy and, if so, which of the two options (chemotherapy or chemoradiotherapy) before surgery gives superior outcomes? Among patients whose inguinal node histology predicts a high risk of recurrence, does prophylactic pelvic lymph node dissection (PLND) plus chemoradiation to the inguinal and pelvic fields improve survival compared to chemoradiation alone? Methods: A Bayesian trial design aims to include a wide population of patients and incorporates two randomisations: InPACT-neoadjuvant and InPACT-pelvis. Participants are stratified by disease burden (extent of nodal involvement), by the presence or absence of high-risk radiological features, and by GFR. Participants with high disease burden where neoadjuvant treatment is thought to be indicated are randomised to neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy. Participants with intermediate disease burden are randomised to one of 3 arms: Surgery alone or neoadjuvant chemoradiotherapy followed by surgery, or neoadjuvant chemotherapy prior to surgery. Participants in the low-burden group proceed directly to surgery. Participants with postoperative inguinal node pathology that shows high-risk features may then proceed to InPACT-pelvis where randomisation is between adjuvant chemoradiotherapy ± PLND for those not previously treated with chemoradiotherapy & between PLND & observation for those previously treated with neoadjuvant chemoradiotherapy. The study aims to recruit 200 participants. The primary outcome measure is overall survival, with secondary outcome measures of disease-specific survival, disease-free survival, and freedom from locoregional recurrence and distant metastasis. Feasibility, toxicity, the type/extent of surgical complications, and quality of life will be assessed as secondary endpoints for all the InPACT treatment arms. To October 2021, 65 participants have been recruited with centres open in the UK, US and Canada. Clinical trial information: NCT02305654.

Objective To analyse the trends in opportunistic PSA screening in A ustralia, focusing on younger men (<55 years of age), to examine the effects of this screening on transrectal ultrasonography ( TRUS )‐guided biopsy rates and to determine the nature of prostate cancers ( PC as) being detected. Subjects and Methods All men who received an opportunistic screening PSA test and TRUS ‐guided biopsy between 2001 and 2008 in A ustralia were analysed using data from the A ustralian C ancer registry ( A ustralian I nstitute of H ealth and W elfare) and Medicare databases. The V ictorian cancer registry was used to obtain G leason scores. Age‐standardized and age‐specific rates were calculated, along with the incidence of PC a, and correlated with G leason scores. Results A total 5 174 031 PSA tests detected 128 167 PC as in the period 2001–2008. During this period, PSA testing increased by 146% (a mean of 4629 tests per 100 000 men annually), with 80 and 59% increases in the rates of TRUS ‐guided biopsy and incidence of PC a, respectively. The highest increases in PSA screening occurred in men <55 years old and up to 1101 men had to be screened to detect one incident case of PC a (0.01%). Screening resulted in two thirds of men aged <55 years receiving a negative TRUS biopsy. There was no correlation with G leason >7 tumours in patients aged <55 years. Conclusion Despite the ongoing controversy about the merits of PCa screening, there was an increase in PSA testing, especially in men <55 years old, leading to a modestly higher incidence of PC a in A ustralia. Overall, PSA screening was associated with high rates of negative TRUS ‐biopsy and the detection of low/intermediate grade PCa among younger patients.