Zie ook de literatuurlijsten niet-toxische middelen en behandelingen specifiek bij de verschillende vormen van kanker en bij chemo, bestraling en operaties van arts-bioloog drs. Engelbert Valstar

En weet dat u als donateur ook korting kunt krijgen op o.a. prostasol bij MEDPRO

5 december 2023: Zie ook dit artikel: https://kanker-actueel.nl/bestraling-radiotherapie-aanvullend-op-hormoontherapie-bij-prostaatkankerpatienten-heeft-alleen-enig-effect-7-procent-op-overall-overleving-bij-weinig-botuitzaaiingen-maximaal-5.html

5 december 2023: Bron: The Lancet en ESMO 2023

Volgens de eindresultaten van de RADICALS-RT-studie, (N = 1396 patiënten) heeft aanvullende radiotherapie / bestraling voor patiënten met een verhoogd risico op een recidief na een radicale prostatectomie - operatie geen zin deze toe te passen omdat er geen verschil werd gezien in 10-jarige overall overleving. De overeenkomstige 10-jaars totale overlevingspercentages waren 88% en 87% respectievelijk voor radiotherapie en wait-and-see / observatie. (HR 0,98; 95% BI 0,67–1,44; p=0,92)

Wel veroorzaakte de radiotherapie / bestraling veel meer bijwerkingen in vergelijking met een wait-and-see beleid in gevallen van PSA stijging. Na 1 jaar waren de zelfgerapporteerde urine-incontinentie en ontlastings-incontinentie significant slechter met aanvullende radiotherapie / bestraling (p≤0,001).

Zie deze grafiek:

Radicals_1764O

Figure. No difference was observed between groups for the primary and secondary outcomes in the RADICALS-RT trial (ESMO Congress 2023, Abstract 1764O)

De RADICALS-RT-studie is de grootste studie waarin aanvullende radiotherapie / bestraling bij prostaatkanker is onderzocht.

De mediane leeftijd van de patiënten was 65 jaar en 37% van de patiënten had een CAPRA-S-score van 6+.
Patiënten met postoperatieve PSA ≤0,2 ng/ml en ≥1 risicofactor (pT3/4, Gleason-score 7–10, positieve marges of preoperatieve PSA ≥10 ng/ml) werden 1:1 gerandomiseerd ingedeeld in twee x twee groepen tot 22 weken na de operatie.
Een groep voor het ontvangen van aanvullende radiotherapie / bestraling of observatie plus palliatieve radiotherapie / bestraling bij biochemische terugval (twee opeenvolgende stijgingen met een PSA ≥0,1 ng/ml of drie opeenvolgende stijgingen).
Stratificatiefactoren waren Gleason-score, margestatus, gepland RT-volume (alleen prostaatbed versus prostaatbed plus bekken), RT-schema (52,5 Gy/20 fracties versus 66 Gy/33 fracties) en centrum.

Een abstract van deze zelfde studie is in 2020 in The Lancet gepubliceerd en nu op ESMO als definitief studieverslag gepresenteerd.

Zie grafiek hierboven voor definitieve resultaten en hier het abstract en volledig studieverslag in PDF formaat van dat moment uit 2020:

ARTICLES| VOLUME 396, ISSUE 10260, P1413-1421, OCTOBER 31, 2020

Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial

Published:September 28, 2020DOI:https://doi.org/10.1016/S0140-6736(20)31553-1

Summary

Background

The optimal timing of radiotherapy after radical prostatectomy for prostate cancer is uncertain. We aimed to compare the efficacy and safety of adjuvant radiotherapy versus an observation policy with salvage radiotherapy for prostate-specific antigen (PSA) biochemical progression.

Methods

We did a randomised controlled trial enrolling patients with at least one risk factor (pathological T-stage 3 or 4, Gleason score of 7–10, positive margins, or preoperative PSA ≥10 ng/mL) for biochemical progression after radical prostatectomy (RADICALS-RT). The study took place in trial-accredited centres in Canada, Denmark, Ireland, and the UK. Patients were randomly assigned in a 1:1 ratio to adjuvant radiotherapy or an observation policy with salvage radiotherapy for PSA biochemical progression (PSA ≥0·1 ng/mL or three consecutive rises). Masking was not deemed feasible. Stratification factors were Gleason score, margin status, planned radiotherapy schedule (52·5 Gy in 20 fractions or 66 Gy in 33 fractions), and centre. The primary outcome measure was freedom from distant metastases, designed with 80% power to detect an improvement from 90% with salvage radiotherapy (control) to 95% at 10 years with adjuvant radiotherapy. We report on biochemical progression-free survival, freedom from non-protocol hormone therapy, safety, and patient-reported outcomes. Standard survival analysis methods were used. A hazard ratio (HR) of less than 1 favoured adjuvant radiotherapy. This study is registered with ClinicalTrials.gov, NCT00541047.

Findings

Between Nov 22, 2007, and Dec 30, 2016, 1396 patients were randomly assigned, 699 (50%) to salvage radiotherapy and 697 (50%) to adjuvant radiotherapy. Allocated groups were balanced with a median age of 65 years (IQR 60–68). Median follow-up was 4·9 years (IQR 3·0–6·1). 649 (93%) of 697 participants in the adjuvant radiotherapy group reported radiotherapy within 6 months; 228 (33%) of 699 in the salvage radiotherapy group reported radiotherapy within 8 years after randomisation. With 169 events, 5-year biochemical progression-free survival was 85% for those in the adjuvant radiotherapy group and 88% for those in the salvage radiotherapy group (HR 1·10, 95% CI 0·81–1·49; p=0·56). Freedom from non-protocol hormone therapy at 5 years was 93% for those in the adjuvant radiotherapy group versus 92% for those in the salvage radiotherapy group (HR 0·88, 95% CI 0·58–1·33; p=0·53). Self-reported urinary incontinence was worse at 1 year for those in the adjuvant radiotherapy group (mean score 4·8 vs 4·0; p=0·0023). Grade 3–4 urethral stricture within 2 years was reported in 6% of individuals in the adjuvant radiotherapy group versus 4% in the salvage radiotherapy group (p=0·020).

Interpretation

These initial results do not support routine administration of adjuvant radiotherapy after radical prostatectomy. Adjuvant radiotherapy increases the risk of urinary morbidity. An observation policy with salvage radiotherapy for PSA biochemical progression should be the current standard after radical prostatectomy.

Funding

Cancer Research UK, MRC Clinical Trials Unit, and Canadian Cancer Society.

Comment in

Timing of radiotherapy after radical prostatectomy.
Tilki D, D'Amico AV.Lancet. 2020 Oct 31;396(10260):1374-1375. doi: 10.1016/S0140-6736(20)31957-7. Epub 2020 Sep 28.PMID: 33002430 No abstract available.
Salvage radiotherapy: a new standard of care.
Sidaway P.Nat Rev Clin Oncol. 2021 Jan;18(1):5. doi: 10.1038/s41571-020-00443-3.PMID: 33067593 No abstract available.
Salvage radiotherapy: a new standard of care.
Sidaway P.Nat Rev Urol. 2020 Dec;17(12):657. doi: 10.1038/s41585-020-00392-7.PMID: 33077912 No abstract available.
Adjuvant Versus Early Salvage Radiation Therapy After Radical Prostatectomy for Men With Adverse Pathologic Features-The Debate Continues.
Chen RC, Choudhury A.Int J Radiat Oncol Biol Phys. 2021 Mar 15;109(4):839-843. doi: 10.1016/j.ijrobp.2020.12.022.PMID: 33610298 Review. No abstract available.
Re: Timing of Radiotherapy After Radical Prostatectomy (RadicalS-RT): A Randomised, Controlled Phase 3 Trial.
Ghadjar P, Wiegel T.Eur Urol. 2021 Jul;80(1):117. doi: 10.1016/j.eururo.2021.02.016. Epub 2021 Feb 19.PMID: 33612373 No abstract available.
Postoperative radiotherapy in prostate cancer.
Ghadjar P, Höcht S, Wiegel T.Lancet. 2021 May 1;397(10285):1623. doi: 10.1016/S0140-6736(21)00273-7.PMID: 33933203 No abstract available.
Radikale Prostatektomie: Adjuvante versus Salvage-Radiatio.
[No authors listed]Aktuelle Urol. 2022 Feb;53(1):12-13. doi: 10.1055/a-1559-4803. Epub 2022 Jan 25.PMID: 35078254 German. No abstract available.
Immediate or salvage radiotherapy after radical prostatectomy: Do we finally know?
Srinivasan S, Kunder S, Maitre P, Murthy V.Natl Med J India. 2021 Sep-Oct;34(5):282-284. doi: 10.25259/NMJI_127_21.PMID: 35593236 No abstract available.

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Urinary Continence Recovery after Retzius-Sparing Robot Assisted Radical Prostatectomy and Adjuvant Radiation Therapy.
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