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NCT Number: NCT05019846

SRT Versus SRT+ADT in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

ASST Spedali Civili of Brescia

Brescia, BS, 25123, Italy

Location status: Recruiting

Location contact

Marco Lorenzo Bonù, MD

CONTACT

[email protected]

+390303995285

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Triptorelin Embonate

Drug

single administration before SRT starting

Bicalutamide 50 mg

Drug

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

Primary outcomes

  1. biochemical disease free survival

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

    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.

Secondary outcomes

  1. Disease free survival

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

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

  2. freedom from local recurrence

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

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

  3. freedom from regional recurrence

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

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

  4. freedom from distant metastasis

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

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

  5. Overall survival

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

    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.

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

    Time frame: 12 weeks after SRT, 3, 6 and 12 months after SRT

    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

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

    Time frame: 12 weeks after SRT, 3, 6 and 12 months after SRT

    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.

  8. patients reported outcome, erectile function assessment,

    Time frame: 12 weeks after SRT, 3, 6 and 12 months after SRT

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

  9. patients reported outcome, prostate related symptoms assessment

    Time frame: 12 weeks after SRT, 3, 6 and 12 months after SRT

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

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

    Time frame: from the beginning of treatment until 6 months after SRT

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Lorenzo Bonù, MD

CONTACT

[email protected]

+390303995285

Sponsors and collaborators

Lead sponsor

Marco Lorenzo Bonu

Other

Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Registry information

Official study title

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

Acronym: SPA

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Aug 25, 2021
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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