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SRT Versus SRT+ADT in Prostate Cancer (SPA)

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Triptorelin Embonate

Bicalutamide 50 mg

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring SRT, ADT, SBRT, high risk prostate cancer, unfavourable intermediate risk prostate cancer, randomized trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

ASST Spedali Civili of BresciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SRT+ADT

SRT alone

Arm Description

Patients 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

Patients 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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

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.

patients reported outcome, erectile function assessment,

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

patients reported outcome, prostate related symptoms assessment

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

Clinician reported Acute Toxicity, assessed with CTCAE 5.0 scales

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

Clinician reported Late Toxicity, assessed with CTCAE 5.0 scales

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

Full Information

NCT ID

NCT05019846

First Posted

August 2, 2021

Last Updated

April 13, 2023

Sponsor

Marco Lorenzo Bonu

Collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

1. Study Identification

Unique Protocol Identification Number

NCT05019846

Brief Title

SRT Versus SRT+ADT in Prostate Cancer

Acronym

SPA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 30, 2021 (Actual)

Primary Completion Date

December 1, 2025 (Anticipated)

Study Completion Date

December 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marco Lorenzo Bonu

Collaborators

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

SRT, ADT, SBRT, high risk prostate cancer, unfavourable intermediate risk prostate cancer, randomized trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SRT+ADT

Arm Type

Experimental

Arm Description

Arm Title

SRT alone

Arm Type

No Intervention

Arm Description

Patients 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).

Intervention Type

Drug

Intervention Name(s)

Triptorelin Embonate

Intervention Description

single administration before SRT starting

Intervention Type

Drug

Intervention Name(s)

Bicalutamide 50 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

biochemical disease free survival

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Disease free survival

Description

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

Time Frame

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

Title

freedom from local recurrence

Description

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

Time Frame

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

Title

freedom from regional recurrence

Description

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

Time Frame

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

Title

freedom from distant metastasis

Description

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

Time Frame

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

Title

Overall survival

Description

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.

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

quality of life, prostate related quality of life questionnarire

Description

Time Frame

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

Title

patients reported outcome, erectile function assessment,

Description

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

Time Frame

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

Title

patients reported outcome, prostate related symptoms assessment

Description

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

Time Frame

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

Title

Clinician reported Acute Toxicity, assessed with CTCAE 5.0 scales

Description

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

Time Frame

from the beginning of treatment until 6 months after SRT

Title

Clinician reported Late Toxicity, assessed with CTCAE 5.0 scales

Description

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

Time Frame

from 6 months after SRT 5 years of follow-up

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

prostate cancer patients

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marco Lorenzo Bonù, MD

Phone

+390303995285

marco.bonu@unibs.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luca Triggiani, MD PHD

Organizational Affiliation

Università degli Studi di Brescia

Official's Role

Principal Investigator

Facility Information:

Facility Name

ASST Spedali Civili of Brescia

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marco Lorenzo Bonù, MD

Phone

+390303995285

dm.radioterapiabs@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

explicit request

IPD Sharing URL

http://dm.radioterapiabs@gmail.com

Learn more about this trial

SRT Versus SRT+ADT in Prostate Cancer

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