NCT03169933

Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma

Completed NA Last updated 6 March 2018

What this trial tests

NA trial testing Combined, intensified and modulated adjuvant radiotherapy in Prostate Cancer in 123 participants. Completed in 2 January 2017.

Timeline

2 January 2004

Primary endpoint
10 January 2009

2 January 2017

Quick facts

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	123
Start date	2 January 2004
Primary completion	10 January 2009
Estimated completion	2 January 2017

Drugs / interventions tested

• Combined, intensified and modulated adjuvant radiotherapy

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

Adults 18 to 79, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with high risk prostate cancer may benefit from radiotherapy after radical prostatectomy. The investigators postulated that adjuvant androgen deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation may improve outcome. A phase II trial was designed to prove that combined-intensified-modulated-adjuvant (CIMA) treatment may improve 5-year biochemical relapse free survival (bRFS) from 75% to 90% in high risk patients. The delivered dose to tumor bed and pelvic nodes was 64.8-70.2 Gy and 45 Gy (57% of patients), respectively, and 69% received ADT.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tailored postoperative treatment of prostate cancer: final results of a phase I/II trial.
   Mantini G, Siepe G, Alitto AR, Buwenge M, et al · · 2018 · cited 2× · PMID 30038390 · DOI 10.1038/s41391-018-0064-7