03 Screening and Active Surveillance

Question 1

ProtecT Trial - Patient Population? Publication?

Answer 1

About 1600, Hamdy NEJM 2023

Question 2

ProtecT Trial - Patient characteristics?

Answer 2

Gleason 6 : 77%
Gleason 7 : 20%
Gleason 8 : 2%

Question 3

ProtecT Trial : Methods?

Answer 3

Active Monitoring vs RT (3DCRT) vs Surgery

Comment: Even though the ProtecT trial is a RCT, it does not
include a formal AS strategy but rather AM (active Monitoring), a significantly less stringent surveillance strategy in terms of clinical follow-up, imaging and repeat biopsies.

Question 4

ProtecT Trial : Results at 10 and 15 years? Mortality, distant mets, disease progression

Answer 4

10yr: AM was as effective as active treatment at 10 years (CSS = 99% vs. 98.8%), but at a cost of increased metastatic progression risk (2.6% vs. 6%).

15yr: No difference in prostate cancer mortality, distant metastases, disease progression between RT & Surgery

Question 5

ProtecT Trial: how well did AS do in this trial?

Answer 5

AS had worse DM, disease progression compared to RT & Surgery

Question 6

ProtecT Trial : Mortality?

Answer 6

Prostate cancer mortality and all cause mortality were similar in all arms.

Question 7

ProtecT Trial : how RT arm performed?

Answer 7

Worse long term loose stools, blood in stool & GI incontinence.

Question 8

Guidelines for screening and early detection (Strong)

Answer 8

Offer early PSA testing to well-informed men at elevated risk of having PCa:
* men from 50 years of age;
* men from 45 years of age and a family history of PCa;
* men of African descent from 45 years of age;
* men carrying BRCA2 mutations from 40 years of age.

Question 9

What are the two distinct strategies for conservative management that aim to reduce over-treatment in PCa

Answer 9

AS and WW

Question 10

Definitions of active surveillance and watchful waiting

Answer 10

Die S3-Leitlinie empfiehlt, den Begriff aktive Überwachung
(active surveillance des Tumors inklusive Kontrollbiopsien mit kurativer Intention und definitiver kurativer Therapie bei Tumorprogress) strikt vom Begriff Watchful Waiting (palliative Strategie mit lediglich symptomatischer Behandlung bei Tumorprogression bei Patienten mit einer Lebenserwartung von unter 10 Jahren) abzugrenzen.

Question 11

Active surveillance

Answer 11

close surveillance through regular followup consisting of PSA, DRU, MRI and repeat prostate biopsies, with curative treatment being prompted by pre-defined thresholds.

Question 12

Watchful waiting

Answer 12

is conservative management for pts deemed unsuitable for curative treatment. Pts are clinically ‘watched’ for the development of local or systemic progression with (imminent) disease-related complaints, at which stage they are then treated palliatively according to their symptoms in order to maintain QoL.

Question 13

Die S3-LL nennt als Voraussetzung einer aktiven
Überwachung 5 Parameter, die erfüllt sein müssen: welche?

Answer 13

• PSA-Wert von maximal 10ng/ml,
• Gleason-Score maximal 6,
• cT1 oder T2,
• Tumornachweis in maximal 2 Stanzzylindern (von 10–12 entnommenen) und
• maximal 50% Tumoranteil in den Stanzzylindern.

Question 14

Verlassen werden soll die aktive Überwachung, wenn der
Patient das wünscht oder wenn eines der folgenden Kriterien
erfüllt ist

Answer 14

• eine PSA-Verdopplungszeit von weniger als 3 Jahren,
• das Auftreten eines Gleason-Scores von 7 oder höher,
• Tumornachweis in mehr als 2 von 10–12 Biopsiezylindern
  oder
• mehr als 50% Tumoranteil in 1 Zylinder (Leitlinie 2021).