Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

IPSEN

External identifiers

EU CT number

2024-520093-34-00

EudraCT number

2020-005754-23

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To determinate if there is improvement in biochemical Disease Free Survival (bDFS) in patients treated with SBRT+ADT versus SBRT alone.

Secondary objectives 1

1. disease free survival (DFS), freedom from local recurrence (FFLR), freedom from regional recurrence (FFRR) freedom from distant metastasis (FFDM), overall survival (OS) acute and late toxicity, quality of life (QoL)

Conditions and MedDRA coding

Acinar cell prostatic carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. • Age 18-80 years old.
2. • Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken
3. • Prostate protocol MRI for local staging
4. • Patients belonging to intermediate unfavorable group according to the D’Amico/NCCN risk group classification: o -Grade group 3 or/and o -2-3 risk factors for intermediate category (PSA 10-20 ng/ml/ Grade group 2-3/ cT2b-cT2c) or/and o -biopsy cores positive ≥50%
5. • Patients belonging to a subclass of high risk group according to the D’Amico/NCCN risk group classification: o -ISUP group 4 (GS 4+4, excluding 3+5 and 5+3) or o -cT3a stage or o PSA>20 ng/ml
6. • Eastern Coooperative Oncology Group (ECOG) PS 0-2
7. • Ability of the patient to understand and sign a written informed consent document
8. • Ability and Willingness to comply with patients reported outcome questionnaires schedule during the study time
9. • IPSS 0-15
10. • Prostate Volume less than 100cc
11. • PSA must be dosed maximum 60 days before randomization
12. • No pathologic lymph nodes and distant metastasis on PET scan (fluorocholine or fluoroPSMA- galliumPSMA ) or CT scan+bone scan.

Exclusion criteria 14

1. • History of Malignant tumors in the previous 2 years excluding non melanoma cancers of the skin. If a patient presents an anamnesis of malignancy (excluding non melanoma skin cancers) it must be free from disease since 24 months at the time of enrollement. Patients affected by hematologic tumors in clinical-radiologic remission since at least 5 years after treatment or after follow-up only for which the prognosis is more than 10 years could be included in the trial after heamtologic consultation clearly declaring the prognosis. (chronic leucemia, phollicolar lymphoma, myelodisplastic syndromes).
2. • Previous prostate surgery other than TURP (at least 6 weeks prior to start of SBRT).
3. • Previous pelvic RT
4. • Prior androgen deprivation therapy (excluding 5alpha reductase inhibitors)
5. • Any prior active treatment for prostate cancer; patients on previous active surveillance are eligible if inclusion criteria are met
6. • Active severe inflammatory bowel disease
7. • Bilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations
8. • Age >80 years.
9. • cT4a, cT3b or pelvic lymph node involvement
10. • Controindication or hypersensitivity to the use of Triptoreline
11. • 5alpha reductase inhibitors not discontinued 4 weeks prior to randomization
12. • History of bone fractures and fall
13. • Risk factors for abnormal heart rhythms or QT prolongation.
14. • Use of concomitant medications that prolong the QT/QTc interval

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • To determinate if there is improvement in biochemical Disease free survival (bDFS, defined as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria*) in patients treated with prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B).

Secondary endpoints 5

1. • Disease free survival (DFS, defined as evidence of biochemical, local, regional or distant relapse on imaging).
2. • Freedom from local recurrence (FFLR, defined as evidence of in-field recurrence detected at imaging and/or Histologically proved)
3. • Freedom from regional recurrence (FFRR, defined as evidence of out-of field recurrence in the true pelvis as defined by TNM VIII criteria for regional node)
4. • Freedom from distant metastasis (FFDM, defined as evidence of out of field recurrence that meets the criteria of M1 defined by TNM VIII)
5. • Overall Survival (OS, defined as death for any cause)

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Sponsor organisation

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Address

Piazzale Spedali Civili 1

City

Brescia

Postcode

25123

Country

Italy

Scientific contact point

Organisation

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Contact name

SC Clinical Trial Center - Dr. Aldo Maria Roccaro

Public contact point

Organisation

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Contact name

SC Clinical Trial Center - Dr. Aldo Maria Roccaro

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Sponsor organisation

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Address

Piazzale Spedali Civili 1

City

Brescia

Postcode

25123

Country

Italy

Locations

1 EU/EEA country · 28 investigational sites

By country

Investigational sites

Results and documents

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

Documents 9 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