Study to assess the safety and efficacy of the SpectraCure P18 System

Overview

Sponsor-declared trial summary

Key facts

Sponsor

SpectraCure AB (publ)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Mar 2024 → ongoing

Decision date (initial)

2023-02-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

(i) demonstrate that the use of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI) is a safe treatment for patients with recurrent prostate cancer, and
(ii) demonstrate that the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) is able to calculate, deliver and control the required light dose for elimination of cancer cells in locally recurrent prostate cancer tumours, and
(iii) demonstrate that the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) is able to calculate the precise positioning of the fibers for maximum effective light delivery, and
(iv) determine the lowest safe and effective drug dose as well as the lowest safe and effective light dose as determined by MRI response and adverse events.
(v) ascertain the dose level and assess clinical efficacy of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI) for treatment of recurrent prostate cancer.

Conditions and MedDRA coding

Recurrent prostate cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 17

1. Phase 1: Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
2. Phase 1: Treatment target volume less than 50 cm3 defined by transrectal ultrasound.
3. Phase 1: Subject not eligible for surgery or curative radiotherapy.
4. Phase 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Phase 1: Expected survival ≥ 8 months.
6. Phase 1: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
7. Phase 1: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
8. Phase 1: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
9. Phase 1: Signed Informed Consent
10. Phase 2: Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
11. Phase 2: Treatment target volume less than 50 cm3.
12. Phase 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
13. Phase 2: Expected survival ≥ 12 months.
14. Phase 2: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
15. Phase 2: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
16. Phase 2: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
17. Phase 2: Signed Informed Consent.

Exclusion criteria 29

1. Phase 1: Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease.
2. Phase 1: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
3. Phase 1: Known allergies to porphyrins.
4. Phase 1: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
5. Phase 1: On-going therapy with a photosensitizing agent.
6. Phase 1: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
7. Phase 1: Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate episodes or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.
8. Phase 1: Patients who have been treated with seed implantation brachytherapy.
9. Phase 1: Gleason score 10 at initial diagnosis.
10. Phase 1: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
11. Phase 1: Concomitant infection
12. Phase 1: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
13. Phase 1: Mental incapacity or psychiatric illness that would interfere with the subject’s ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.
14. Phase 1: Contraindication for photosensitizer
15. Phase 1: Porphyria or other diseases exacerbated by light.
16. Phase 1: Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrast reactions.
17. Phase 2: Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
18. Phase 2: Subjects who have been treated with seed implantation brachytherapy
19. Phase 2: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
20. Phase 2: Concomitant infection.
21. Phase 2: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
22. Phase 2: Mental incapacity or psychiatric illness that would interfere with the subject’s ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.
23. Phase 2: Contraindication for photosensitizer.
24. Phase 2: Porphyria or other diseases exacerbated by light.
25. Phase 2: Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
26. Phase 2: Known allergies to porphyrins.
27. Phase 2: Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
28. Phase 2: On-going therapy with a photosensitizing agent.
29. Phase 2: Enrollment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Phase 1: Safety will be evaluated by toxicity related to protocol therapy, scored according to CTCAE v4.0. In addition, PDT-mediated severe damage to the periprostatic tissues, including the rectal wall, will be evaluated by contrast-enhanced and non-contrast MRI images obtained 5-9 days following PDT.
2. Phase 1: Performance endpoint for the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects.
3. Phase 2: Efficacy - Percentage of subjects with negative biopsies (histopathologically tumor-free) 6 months after PDT procedure. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful.

Secondary endpoints 4

1. Phase 1: Adequacy of effectiveness will be evaluated by MRI within one week to determine the extent of necrosis in the prostate (>70% of target volume in >50% of subjects).
2. Phase 2: Efficacy - Percentage of subjects with remaining localized tumour evaluated by MRI 12 months following PDT. Percentage of subjects with biochemical failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir obtained 6 weeks following PDT, confirmed by a second PSA value 4 weeks later. Percentage of subjects with extra prostatic or distant disease evaluated by PSMA PET 12 months following PDT in case of biochemical failure.
3. Phase 2: Performance - The SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) will be evaluated by light dose-volume histograms for the light dose coverage. Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects.
4. Phase 2: Safety - Adverse events will be collected throughout the study. Assessment of toxicity according to CTCAE v5.0 related to therapy per protocol. In addition, any PDT-mediated severe damage to the periprostatic tissues will be evaluated by MRI images obtained 5-9 days post-PDT. The threshold for success is anticipated to be no Grade 3 toxicity to the rectum or bladder assessed on MRI or any drug-related Serious Adverse Events.

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

SpectraCure AB (publ)

Sponsor organisation

SpectraCure AB (publ)

Address

Gasverksgatan 1, St Peters Kloster St Peters Kloster

City

Lund

Postcode

222 29

Country

Sweden

Scientific contact point

Organisation

SpectraCure AB (publ)

Contact name

Public Contact Point

Public contact point

Organisation

SpectraCure AB (publ)

Contact name

Public Contact Point

Third parties 4

Locations

2 EU/EEA countries · 2 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 14 files

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

Application history

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