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AzTrials

Prostate CancerPhase 3SPANCT05019846

SRT Versus SRT+ADT in Prostate Cancer

A Phase 3 study testing Triptorelin Embonate and Bicalutamide 50 mg in people with Prostate Cancer, run by Marco Lorenzo Bonu at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT). Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Triptorelin Embonate and Bicalutamide 50 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
1 siteItaly
Study dates
30 Sep 2021to 1 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
  • Previous prostate surgery other than TURP (at least 6 weeks prior to start of SBRT).
  • Previous pelvic RT
  • Prior androgen deprivation therapy (excluding 5alpha reductase inhibitors)
  • Any prior active treatment for prostate cancer; patients on previous active surveillance are eligible if inclusion criteria are met
  • Active severe inflammatory bowel disease
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  • Bilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations
  • Age >80 years.
  • cT4a, cT3b or pelvic lymph node involvement
  • Controindication or hypersensitivity to the use of Triptoreline
  • 5alpha reductase inhibitors not discontinued 4 weeks prior to randomization
  • History of bone fractures and fall
  • Risk factors for abnormal heart rhythms or QT prolongation.
  • Use of concomitant medications that prolong the QT/QTc interval

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marco Lorenzo Bonù, MD contact

+390303995285

marco.bonu@unibs.it

Italy1 site, 1 recruiting

  • ASST Spedali Civili of Brescia

    Brescia, BS, 25123

    Marco Lorenzo Bonù, MD, +390303995285, dm.radioterapiabs@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.

To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT).

In intermediate unfavorable risk group, when choosing standard external beam radiotherapy, short term ADT is superior in terms of biochemical disease free survival (bDFS) to EBRT alone. In high risk disease, results of the combination therapy are even more clear. Prostate SRT has been endorsed as option for primary radical treatment for prostate cancer. In such patients, the benefit of ADT is still unknown and the decision is left to clinical judgement.

For these reasons, it seems to be relevant to propose a randomized, open label, phase III clinical trial of prostate SBRT + 6 months ADT versus prostate SBRT alone in intermediate unfavorable and a subgroup of high risk prostate cancer patients.

Conditions
Prostate Cancer
Being tested
Triptorelin Embonate, Bicalutamide 50 mg
Keywords
SRT, ADT, SBRT, high risk prostate cancer, unfavourable intermediate risk prostate cancer, randomized trial
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triptorelin EmbonateDrug

    single administration before SRT starting

  • Bicalutamide 50 mgDrug

    1 dose each day, 7 days before LHRH until 10 days after LHRH administration

Study groups in NCT05019846
Study groupRoleWhat they receive
SRT+ADTExperimentalPatients in ARM A will be treated with SRT on the prostate (consecutive days or at alternate days to a total dose of 36.25 Gy administered in 5 fraction (7.25 Gy/fraction) + LHRH analogue (Triptoreline 22.5 mg). An anti-androgen drug (es. Bicalutamide 50 mg) must be administered daily starting from 7 days before LHRH analogue administration to 10 days after to prevent the flare effect
Receives: Drug: Triptorelin Embonate; Drug: Bicalutamide 50 mg
SRT aloneNo interventionPatients in ARM B will be treated with SRT on prostate alone at a total dose of 36.25 Gy administered daily or on alternate days in 5 fraction (7.25 Gy/fraction).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. biochemical disease free survival

    form the date of the end of radiotherapy to the date of PSA meeting protocol criteria for biochemical relapse or last Follow-up visit. Outcome is mesured in months.

    Measured: outcome will be evaluated at the completion of 5 years of follow-up

Secondary outcomes (11)

  1. Disease free survival

    from the date of the end of radiotherapy to the date of relapse (any) or last Follow-up visit.Outcome is mesured in months.

    Measured: outcome will be evaluated at the completion of 5 years of follow-up

  2. freedom from local recurrence

    from the date of the end of radiotherapy to the date of local relapse or last Follow-up visit. Outcome is mesured in months.

    Measured: outcome will be evaluated at the completion of 5 years of follow-up

  3. freedom from regional recurrence

    from the date of the end of radiotherapy to the date of regional relapse or last Follow-up visit. Outcome is mesured in months.

    Measured: outcome will be evaluated at the completion of 5 years of follow-up

  4. freedom from distant metastasis

    from the date of the end of radiotherapy to the date of metastatic relapse or last Follow-up visit. Outcome is mesured in months.

    Measured: outcome will be evaluated at the completion of 5 years of follow-up

  5. Overall survival

    from the date of the end of radiotherapy to the date of death 8any cause) or last Follow-up visit. Outcome is mesured in months.

    Measured: outcome will be evaluated at the completion of 5 years of follow-up

  6. quality of life, prostate related quality of life in prostate cancer

    scored with questionnaire Expandend Prostate cancer Index Composite-26 (EPIC-26), score scale is 0-100 with higher scores representing better health related quality of life

    Measured: 12 weeks after SRT, 3, 6 and 12 months after SRT

  7. quality of life, prostate related quality of life questionnarire

    scored with questionnaire European organization for research and treatment of cancer PR 25, (EORTC PR 25), All of the scales and single-item measures range in score from 0 to 100. A high score for the Sexual Activity and Sexual Functioning scales represents a high level of functioning, whereas a high score for the Urinary, Bowel, and Hormonal Treatment Related symptoms scales and Incontinence Aid item represents a high level of symptomatology or problems.

    Measured: 12 weeks after SRT, 3, 6 and 12 months after SRT

  8. patients reported outcome, erectile function assessment,

    scored with questionnaire International Index of Erectile Function 5 (IIEF from 25 (best) to 5 (worse))

    Measured: 12 weeks after SRT, 3, 6 and 12 months after SRT

  9. patients reported outcome, prostate related symptoms assessment

    scored with questionnaire Internation Prostate syntoms scale (IPSS, from 0 (best) to 35 (worse))

    Measured: 12 weeks after SRT, 3, 6 and 12 months after SRT

  10. Clinician reported Acute Toxicity, assessed with CTCAE 5.0 scales

    Outcome is mesured in 0-5 scale (higher scale worse toxicity)

    Measured: from the beginning of treatment until 6 months after SRT

  11. Clinician reported Late Toxicity, assessed with CTCAE 5.0 scales

    Outcome is mesured in 0-5 scale (higher scale worse toxicity)

    Measured: from 6 months after SRT 5 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start30 Sep 2021
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05019846
Sponsor's protocol ID
SPA Trial vers. 1.1
Other IDs
2020-005754-23
Acronym
SPA
Status last verified
Apr 2023
First submitted
2 Aug 2021
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Concurrently with the publication of study results concerning efficacy, we will deliver a completely deidentified data set to an appropriate data archive for sharing purposes.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin Embonate and Bicalutamide 50 mg in people with Prostate Cancer, run by Marco Lorenzo Bonu at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marco Lorenzo Bonù, MD (+390303995285, marco.bonu@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

biochemical disease free survival (time frame: outcome will be evaluated at the completion of 5 years of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05019846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.

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