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Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness (ESTABLISH)

Primary Purpose

Prostate Cancer

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Early salvage radiotherapy (eSRT)

Delayed Salvage radiotherapy (dSRT)

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate carcinoma, salvage therapy, biochemical relapse

Eligibility Criteria

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

Inclusion Criteria:

> 18 years of age
Pathologically confirmed invasive prostate carcinoma with minimal 1 risk factor (RF) after radical prostatectomy (RP)
Patient refuses the adjuvant therapy after normalization of urinary function within 6 month after RP
Signed informed consent to participate in the study and (where necessary) consent to participate in the translational part of the research (not a requirement)
ECOG 0 - 1
pT2 and minimal 1 risk factor (RF):
- R1 (PSM), and/or
- Gleason score (4+3=7) 8-10 and/or ISUP grade group 3-5
pT3a /pT3b with or without one RF
No evidence of suspicious pelvic lymph nodes by initial diagnostic: cN0 and/or pN0
No evidence of suspicious distant metastases by initial diagnostic: M0
Patient with decline of PSA level to undetectable PSA levels (< 0,1 ng/ml) or around 0,2ng/ml and with another decreasing trends so that the PSA level decline within 12-24 weeks after RP to undetectable levels (< 0,1 ng/ml) and with renewed increase of PSA >0,2 ng/ml (BCR= biochemical relapse) without any clinical relapse on PSMA PET/CT
No hormonal therapy prior and /or after the radical prostatectomy
Patient suitable and fit for subsequent radiotherapy with high likelihood of good compliance to the follow-up

Exclusion Criteria:

Life expectancy (based on Charlson comorbidity index) < 10 years
Patient not fit for the therapy
History of other cancer (other than a radically removed non-melanoma skin carcinoma)
Previous pelvic irradiation
Active immunosuppressive medication
History of hormone therapy prior to randomization
cN1 and/or pN1 and M1
PSA-persistence after RP (PSA 12-weeks after RP > 0.1 ng/ml or no decreasing trend described in Inclusion criteria)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A- early salvage radiotherapy (eSRT)

Arm B- delayed salvage radiotherapy (dSRT)

Arm Description

Early salvage radiotherapy (eSRT) will be administered immediately after the confirmation of the biochemical relapse (prostate-specific antigen PSA level increase to ≈ 0,2 ng/ml) after radical prostatectomy with defined risk factors and no clinical recurrence signs on prostate specific membrane antigen positron emission tomography and computed tomography (PSMA PET/CT).

The patient is by the biochemical relapse analysis (PSA level 0,2 ng/ml) referred for further follow-up of PSA values. dSRT is initiated, if PSA further increase to values of ≥ 0.4 ng/ml is confirmed and the presence of a potential clinical relapse is excluded with repeated PSMA-PET-CT in line with standard procedures

Outcomes

Primary Outcome Measures

Event-free survival (EFS)

Defined as a time to re-documented biochemical relapse after salvage therapy (bRFS), demonstration of clinical relapse (i.e.,local relapse /lRFS/, locoregional relapse /lrRFS/, distant relapse /MFS/) and/or death from any cause.

Secondary Outcome Measures

Carcinoma-specific survival (CSS)

Overall survival (5y- and 10y- OS)

Incidence of treatment-related acute and late toxicity

Comparison of the incidence of treatment-related acute and late toxicity between patients after early/ delayed salvage therapy. Acute and late toxicity will be assessed and graded using Common Terminology Criteria for Adverse Events (CTCAE).

Health-related quality of life (QoL) assessment.

The analysis of the QoL of both study ARMs will be made based on EORTC validated questionnaires (QLQ-C30 and QLQ-PR25). QLQ-C30 was developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. The EORTC QLQ-PR25 is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 25 items specifically related to prostate cancer.

Full Information

NCT ID

NCT05232578

First Posted

November 24, 2021

Last Updated

August 2, 2022

Sponsor

General University Hospital, Prague

1. Study Identification

Unique Protocol Identification Number

NCT05232578

Brief Title

Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness

Acronym

ESTABLISH

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

December 2032 (Anticipated)

Study Completion Date

December 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

General University Hospital, Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of the trial is to compare the impact and safety of delayed salvage therapy (dSRT, i.e., SRT initiated at PSA values of 0.4-0.5 ng/ml) to those of early salvage therapy (eSRT, i.e., at PSA levels of 0.2 ng/ml) in patients with biochemical relapse after radical prostatectomy. The secondary objective of the trial is to perform analysis of the subgroups of patients to determine which patients are most likely to benefit from dSRT Exploratory objective of the trial is to determine whether selected molecular genetic parameters (172 candidate genes and molecular alterations) and known clinical parameters can be used to identify potential predictors of worse prognosis in patients with known risk factors for relapse after radical prostatectomy, thereby augmenting and refining patient stratification, optimizing their therapy, and clarifying the proper timing of multimodal therapy

6. Conditions and Keywords

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

Prostate Cancer

Keywords

prostate carcinoma, salvage therapy, biochemical relapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

A "balanced design" is used for the 1:1 randomization into two arms A and B:

Masking

None (Open Label)

Allocation

Randomized

Enrollment

380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A- early salvage radiotherapy (eSRT)

Arm Type

Experimental

Arm Description

Arm Title

Arm B- delayed salvage radiotherapy (dSRT)

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Early salvage radiotherapy (eSRT)

Intervention Description

eSRT administered immediately after the confirmation of the biochemical relapse (PSA ≈ 0.2ng/ml). 66-70Gy will be delivered to the bed of prostate. Radiotherapy will be optionally accompanied by androgen deprivation therapy.

Intervention Type

Radiation

Intervention Name(s)

Delayed Salvage radiotherapy (dSRT)

Intervention Description

dSRT administered if PSA levels increase to ≥ 0.4 ng/ml. 66-70Gy will be delivered to the bed of prostate. Radiotherapy will be optionally accompanied by androgen deprivation therapy.

Primary Outcome Measure Information:

Title

Event-free survival (EFS)

Description

Time Frame

Analysed 3 years after randomisation of the last patient.

Secondary Outcome Measure Information:

Title

Carcinoma-specific survival (CSS)

Time Frame

Analysed 5/10 years after randomization of the last patient.

Title

Overall survival (5y- and 10y- OS)

Time Frame

Analysed 5/10 years after randomization of the last patient.

Title

Incidence of treatment-related acute and late toxicity

Description

Time Frame

Analysed 5 years after randomization of the last patient.

Title

Health-related quality of life (QoL) assessment.

Description

Time Frame

Analysed 5 years after randomization of the last patient.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: > 18 years of age Pathologically confirmed invasive prostate carcinoma with minimal 1 risk factor (RF) after radical prostatectomy (RP) Patient refuses the adjuvant therapy after normalization of urinary function within 6 month after RP Signed informed consent to participate in the study and (where necessary) consent to participate in the translational part of the research (not a requirement) ECOG 0 - 1 pT2 and minimal 1 risk factor (RF): R1 (PSM), and/or Gleason score (4+3=7) 8-10 and/or ISUP grade group 3-5 pT3a /pT3b with or without one RF No evidence of suspicious pelvic lymph nodes by initial diagnostic: cN0 and/or pN0 No evidence of suspicious distant metastases by initial diagnostic: M0 Patient with decline of PSA level to undetectable PSA levels (< 0,1 ng/ml) or around 0,2ng/ml and with another decreasing trends so that the PSA level decline within 12-24 weeks after RP to undetectable levels (< 0,1 ng/ml) and with renewed increase of PSA >0,2 ng/ml (BCR= biochemical relapse) without any clinical relapse on PSMA PET/CT No hormonal therapy prior and /or after the radical prostatectomy Patient suitable and fit for subsequent radiotherapy with high likelihood of good compliance to the follow-up Exclusion Criteria: Life expectancy (based on Charlson comorbidity index) < 10 years Patient not fit for the therapy History of other cancer (other than a radically removed non-melanoma skin carcinoma) Previous pelvic irradiation Active immunosuppressive medication History of hormone therapy prior to randomization cN1 and/or pN1 and M1 PSA-persistence after RP (PSA 12-weeks after RP > 0.1 ng/ml or no decreasing trend described in Inclusion criteria)

Central Contact Person:

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

Sona Argalacsova, MD, PhD

Phone

+420224962219

sona.argalacsova@vfn.cz

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

Otakar Capoun, MD, PhD

Phone

+420224962219

otakar.capoun@vfn.cz

12. IPD Sharing Statement

Plan to Share IPD

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