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Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer (GrandP/SPCG19)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Radiotherapy or surgery
initial observation
Hormone therapy
Sponsored by
Sven Löffeler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, older patients, immediate curative treatment, conservative treatment

Eligibility Criteria

75 Years - undefined (Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Participant must be 75 years of age or older, at the time of signing the informed consent.

  2. Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score >14, or reversibly frail; miniCOGTM: score >2)

    And who have PCa (diagnosed ≤6 months) with one or both of the following features:

    • Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5)
    • Locally advanced PCa (T3 or T4) (unequivocal findings of clinical/ radiological T3 or clinical/ radiological T4 on DRE or MRI; broad capsular contact of tumor on MRI is treated as localized disease, T2, in the context of this study)
    • Able to read, understand and fill in HRQoL questionnaires (PROMS)
  3. Male
  4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

Medical Conditions

  1. Dementia (unable to consent) Prior/Concomitant Therapy
  2. Prior radiation to the pelvis
  3. Hormone therapy >3 months prior to randomization Diagnostic assessments
  4. Lymph node metastasis (N0) on MRI, CT or PSMA-PET CT (equivocal N-findings =N0; borderline cases will be discussed and called by a study tumor board).

  5. Distant metastasis (M0) on MRI, CT, bone scan or PSMA-PET CT (equivocal bone scan findings need to be confirmed with MRI or CT; borderline cases will be discussed by a study tumor board).

    Other Exclusions

  6. Disabled or severe comorbidity (identified by G8 screening)
  7. Unable to read, understand or fill out HRQoL questionnaires (PROMS)

Sites / Locations

  • RigshospitalRecruiting
  • Odense University Hospital
  • Tampere University HospitalRecruiting
  • Sunmøre Hospital TrustRecruiting
  • Stavanger University HospitalRecruiting
  • Sørlandet Hospital TrustRecruiting
  • St. Olavs HospitalRecruiting
  • Vestfold Hospital Trust (Hospital of Vestfold)Recruiting
  • Innlandet Hospital TrustRecruiting
  • Akerhus University HospitalRecruiting
  • Oslo University HospitalRecruiting
  • University Hospital of Northern NorwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

immediate curative therapy

initial observation/ hormone therapy

Arm Description

Patients randomized to the intervention arm will receive immediate curative therapy in the form of either radiotherapy to the prostate in combination with hormone therapy (ADT or monotherapy) or surgery (radical prostatectomy). Standard treatment in this arm is radiotherapy + hormone therapy. Surgery is reserved for patients with strong preferences against radiotherapy.

Patients in this arm will either be observed (with localized high-risk prostate cancer) or receive hormone therapy (locally advanced prostate cancer; ADT or monotherapy). Further local or systemic therapy is given at doctor's discretion triggered by local or/ and systemic progression.

Outcomes

Primary Outcome Measures

Overall survival
overall survival
Burden of disease
European Organisation for Research and Treatment of Cancer questionnaire for assessment of health-related quality of life elderly patients with cancer (EORTC ELD 14), burden of disease scale (2 questions, score 0-100, high scores indicate high burden of disease)

Secondary Outcome Measures

Role functioning
European Organisation for Research and Treatment of Cancer questionnaire for quality of life of cancer patients (EORTC-QLQ-C30), RF2 scale (2 questions, score 0-100, high scores indicate a high / healthy level of functioning)
Urinary irritative/ obstructive symptoms
Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26),urinary scales (score 0-100, higher scores indicating better outcomes)
bowel symptoms
Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), bowel scales (score 0-100, higher scores indicating better outcomes)
Prostate cancer morbidity
hospitalizations, interventions, complications due to local progression/ systemic progression)
Prostate-cancer-specific survival
Prostate cancer deaths in intervention and control group
Metastasis-free survival
time to metastasis detected radiographically due to symptoms or biochemical progression
Symptom-/ intervention-free survival
time to symptoms/ need for interventions due to prostate cancer progression
Quality of life-adjusted years
Euro QoL group questionaire (EQ-5D-5L) (1 =full health; 0= dead)
need for secondary and tertiary therapy
use of second- and third-line therapies

Full Information

First Posted
June 22, 2022
Last Updated
September 21, 2023
Sponsor
Sven Löffeler
Collaborators
Oslo University Hospital, Klinbeforsk
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1. Study Identification

Unique Protocol Identification Number
NCT05448547
Brief Title
Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
Acronym
GrandP/SPCG19
Official Title
A Randomized, Open-label, Multicenter, Parallel Group Treatment, Phase 3, Two-arm Study to Measure the Effect on Overall Survival and Quality of Life of Immediate Curative Therapy Compared With Standard Conservative Treatment in Older Male Participants Aged ≥ 75 Years With Non-metastatic, High-risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
December 31, 2029 (Anticipated)
Study Completion Date
December 31, 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sven Löffeler
Collaborators
Oslo University Hospital, Klinbeforsk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is currently unclear if immediate curative treatment (radiotherapy or surgery) of high-risk prostate cancer without metastasis in older men (>=75 years) generates the same survival benefits as in younger patients or if the harms/ side-effects of immediate curative treatment outweigh the benefits. In this study the investigators randomize older patients with high-risk, non-metastatic high-risk prostate cancer to either immediate curative therapy or to conservative, more problem-oriented therapy to investigate if immediate curative treatment prolongs life, improves quality of life and is cost-effective.
Detailed Description
There is a lack of both level 1 evidence and consensus regarding the optimal treatment strategy for older men (>=75 years) with non-metastatic, high-risk prostate cancer. Currently, in Scandinavia, the majority of older patients are treated conservatively, i.e. with hormone therapy or watchful waiting while some centers recommend immediate curative therapy regardless of patient age. Older patients thus risk both undertreatment and overtreatment of their cancer. This randomized clinical trial investigates if immediate curative therapy of high-risk, non-metastatic prostate cancer prolongs life (as it does in younger patients) and improves health-related quality of life. Furthermore, this trial investigates if the early side effects of immediate curative therapy are compensated by better long-term tumor control, better quality of life, functional status and improved survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, older patients, immediate curative treatment, conservative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized, parallel, open-label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
980 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
immediate curative therapy
Arm Type
Experimental
Arm Description
Patients randomized to the intervention arm will receive immediate curative therapy in the form of either radiotherapy to the prostate in combination with hormone therapy (ADT or monotherapy) or surgery (radical prostatectomy). Standard treatment in this arm is radiotherapy + hormone therapy. Surgery is reserved for patients with strong preferences against radiotherapy.
Arm Title
initial observation/ hormone therapy
Arm Type
Active Comparator
Arm Description
Patients in this arm will either be observed (with localized high-risk prostate cancer) or receive hormone therapy (locally advanced prostate cancer; ADT or monotherapy). Further local or systemic therapy is given at doctor's discretion triggered by local or/ and systemic progression.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy or surgery
Intervention Description
see arm/ group description
Intervention Type
Other
Intervention Name(s)
initial observation
Intervention Description
see arm/ group description
Intervention Type
Drug
Intervention Name(s)
Hormone therapy
Intervention Description
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy
Primary Outcome Measure Information:
Title
Overall survival
Description
overall survival
Time Frame
10 years following end of recruitment
Title
Burden of disease
Description
European Organisation for Research and Treatment of Cancer questionnaire for assessment of health-related quality of life elderly patients with cancer (EORTC ELD 14), burden of disease scale (2 questions, score 0-100, high scores indicate high burden of disease)
Time Frame
0-10 years
Secondary Outcome Measure Information:
Title
Role functioning
Description
European Organisation for Research and Treatment of Cancer questionnaire for quality of life of cancer patients (EORTC-QLQ-C30), RF2 scale (2 questions, score 0-100, high scores indicate a high / healthy level of functioning)
Time Frame
0-10 years
Title
Urinary irritative/ obstructive symptoms
Description
Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26),urinary scales (score 0-100, higher scores indicating better outcomes)
Time Frame
0-10 years
Title
bowel symptoms
Description
Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), bowel scales (score 0-100, higher scores indicating better outcomes)
Time Frame
0-10 years
Title
Prostate cancer morbidity
Description
hospitalizations, interventions, complications due to local progression/ systemic progression)
Time Frame
0-10 years
Title
Prostate-cancer-specific survival
Description
Prostate cancer deaths in intervention and control group
Time Frame
0-10 years
Title
Metastasis-free survival
Description
time to metastasis detected radiographically due to symptoms or biochemical progression
Time Frame
0-10 years
Title
Symptom-/ intervention-free survival
Description
time to symptoms/ need for interventions due to prostate cancer progression
Time Frame
0-10 years
Title
Quality of life-adjusted years
Description
Euro QoL group questionaire (EQ-5D-5L) (1 =full health; 0= dead)
Time Frame
0-10 years
Title
need for secondary and tertiary therapy
Description
use of second- and third-line therapies
Time Frame
0-10 years
Other Pre-specified Outcome Measures:
Title
Institutionalized care
Description
at each follow-up visit the living status of the patients will be assessed. If patients have become dependent on permanent nursing home/ assisted care this will be registered.
Time Frame
0-10 years
Title
Health-related quality of life in cancer patients
Description
European Organisation for Research and Treatment of Cancer questionnaire for quality of life of cancer patients (EORTC-QLQ-C30), scales not primary/ secondary outcome measures (All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems)
Time Frame
0-10 years
Title
Health-related quality of life in older cancer patients
Description
European Organisation for Research and Treatment of Cancer questionnaire for quality of life of cancer patients (EORTC-QLQ-C30), scales not primary outcome (All of the scales and single-item measures range in score from 0 to 100. High scores indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose)
Time Frame
0-10 years
Title
Quality of Life issues in patients with prostate cancer
Description
Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), scales not secondary outcomes (score 0-100, higher scores indicating better outcomes)
Time Frame
0-10 years
Title
Instrumental activities of daily living (iADL)
Description
Lawton and Brody questionnaire (8 questions, minimum score 0, maximum score 5, higher scores indicating need for assistance)
Time Frame
0-10 years
Title
Personal activities of daily living (pADL)
Description
Lawton and Brody questionnaire (6 questions, minimum score 0, maximum score 5, higher scores indicating need for assistance)
Time Frame
0-10 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only males have prostate cancer
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant must be 75 years of age or older, at the time of signing the informed consent. Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score >14, or reversibly frail; miniCOGTM: score >2) And who have PCa (diagnosed ≤6 months) with one or both of the following features: Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5) Locally advanced PCa (T3 or T4) (unequivocal findings of clinical/ radiological T3 or clinical/ radiological T4 on DRE or MRI; broad capsular contact of tumor on MRI is treated as localized disease, T2, in the context of this study) Able to read, understand and fill in HRQoL questionnaires (PROMS) Male Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Medical Conditions Dementia (unable to consent) Prior/Concomitant Therapy Prior radiation to the pelvis Hormone therapy >3 months prior to randomization Diagnostic assessments Lymph node metastasis (N0) on MRI, CT or PSMA-PET CT (equivocal N-findings =N0; borderline cases will be discussed and called by a study tumor board). Distant metastasis (M0) on MRI, CT, bone scan or PSMA-PET CT (equivocal bone scan findings need to be confirmed with MRI or CT; borderline cases will be discussed by a study tumor board). Other Exclusions Disabled or severe comorbidity (identified by G8 screening) Unable to read, understand or fill out HRQoL questionnaires (PROMS)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Loffeler, MD, PhD
Phone
+47 92235628
Email
sven.loffeler@siv.no
First Name & Middle Initial & Last Name or Official Title & Degree
Erik S Haug, MD, PhD
Phone
+47 93030298
Email
erik.haug@siv.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Loffeler, MD, PhD
Organizational Affiliation
The Hospital of Vestfold
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Brasso, Prof, PhD
Phone
+45 35 45 35 45
Email
klaus.brasso@regionh.dk
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mads H Poulsen, MD, PhD
Phone
+45 63 20 20 00
Email
mads.poulsen@mail.dk
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teemu Murtola, Prof, PhD
Phone
+358 3 311 611
Email
teemu.murtola@tuni.fi
Facility Name
Sunmøre Hospital Trust
City
Ålesund
State/Province
Møre Og Romsdal
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjørg Aksnessæther
Phone
+47 70105000
Email
bjorg.y.aksnessether@helse-mr.no
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Nyre Vigmostad, MD
Phone
+47 51518000
Email
marianyr@gmail.com
Facility Name
Sørlandet Hospital Trust
City
Kristiansand
State/Province
Sørlandet
ZIP/Postal Code
4604
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Müller, MD, PhD
Phone
+47 90610600
Email
christoph.muller@sshf.no
Facility Name
St. Olavs Hospital
City
Trondheim
State/Province
Trøndelag
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torgrim M Tandstad, MD, PhD, Professor
Phone
+47 72573000
Email
Torgrim.Tandstad@stolav.no
Facility Name
Vestfold Hospital Trust (Hospital of Vestfold)
City
Tønsberg
State/Province
Vestfold
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Löffeler
Phone
+4733342000
Ext
+4733342000
Email
sven.loffeler@siv.no
First Name & Middle Initial & Last Name & Degree
Erik S Haug
Phone
+4733342000
Ext
+4733342000
Email
erik.haug@siv.no
Facility Name
Innlandet Hospital Trust
City
Hamar
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola Christiansen, MD
Phone
+47 915 06 200
Email
ola.christiansen@sykehuset-innlandet.no
Facility Name
Akerhus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsti Aas, MD, PhD
Phone
+47 55 97 50 00
Email
kirstiaas@hotmail.com
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian Thon, MD, PhD
Phone
+47 98227869
Email
uxktho@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Anne Marie Holck Storås, MD, PhD
Phone
+47 93208884
Email
ANNHOL@ous-hf.no
Facility Name
University Hospital of Northern Norway
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hege S Haugnes, Prof, PhD
Phone
+47 776 26000
Email
hege.sagstuen.haugnes@unn.no

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only anonymized data will be shared

Learn more about this trial

Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer

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