Artificial Intelligence driven personalisation of radiotherapy and concomitant androgen deprivation therapy for prostate cancer patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Linac-Pet Scan Opco Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

21 Oct 2024 → ongoing

Decision date (initial)

2024-05-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

The individualization of radiotherapy (RT) based on prostate-specific membrane antigen positron emission tomography / computed tomography (PSMA PET/CT) imaging and a multimodal artificial intelligence (MMAI) system in terms de-intensification of hormonal therapy in parallel to ultra-hypofractionated RT and dose escalation to the prostate has no decreased disease-free survival. A reduction both in overall treatment duration (6 fractions) and shortening of proposed ADT will further increase the patients’ convenience.

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
2. High- or very hih-risk according to NCCNv4.2023 criteria
3. Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI))
4. Signed written informed consent for this study
5. Age >18 years
6. Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
7. MMAI low-/intermediate-risk
8. ECOG Performance score 0 or 1
9. IPSS Score ≤15
10. Prostate biopsy core with the highest ISUP grade available

Exclusion criteria 22

1. Prior radiotherapy to the prostate or pelvis
2. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
3. Contraindication to undergo a MRI scan
4. Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anaesthesia)
5. Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
6. Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
7. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
8. Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
9. Participation in any other interventional clinical trial within the last 30 days before the start of this trial
10. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
11. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
12. Prior radical prostatectomy
13. Known or persistent abuse of medication, drugs or alcohol
14. Patients expected to have severe set up problems (e.g. mental condition)
15. Prior focal therapy approaches to the prostate
16. Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT
17. Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT
18. Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is >2 months
19. Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
20. PSA >50 ng/ml prior to starting of systemic therapy
21. Expected patient survival <5 years
22. Contraindication to Goserelin

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-free survival 5 years after treatment. Disease recurrence is defined as PSA failure according to Phoenix, new lesions on PSMA PET and/or MRI imaging or the beginning of any salvage therapy.

Secondary endpoints 8

1. Time to local or regional failure; after end of RT. Local or regional recurrences have to be confirmed by PSMA-PET or mpMR imaging. For the diagnosis of local failure, verification via biopsy is warranted.
2. Metastatic free survival (MFS) after end of RT, (all metastases have to be confirmed by PSMA-PET/CT or mpMR imaging)
3. Overall (OS) and prostate cancer specific (PCSS) survival after end of RT
4. Time to biochemical failure after end of RT (phoenix definition)
5. Patient reported quality of life (QOL: EPIC-CP, IPSS and IIEF-5)
6. Cumulative acute genitourinary (GU) and gastrointestinal (GI) toxicities during and up to 3 months after RT using the RTOG criteria
7. Cumulative chronic GU and GI toxicities after RT using the RTOG and CTCAEv5.0 criteria
8. Testosterone recovery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Linac-Pet Scan Opco Limited

Sponsor organisation

Linac-Pet Scan Opco Limited

Address

Nikis Avenue 1

City

Limassol

Postcode

4108

Country

Cyprus

Scientific contact point

Organisation

Linac-Pet Scan Opco Limited

Contact name

Constantinos Zamboglou

Public contact point

Organisation

Linac-Pet Scan Opco Limited

Contact name

Kristis Vevis

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications