NCT05448547

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
980

participants targeted

Target at P75+ for phase_3 prostate-cancer

Timeline
129mo left

Started Nov 2022

Longer than P75 for phase_3 prostate-cancer

Geographic Reach
4 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Nov 2022Dec 2036

First Submitted

Initial submission to the registry

June 22, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

July 1, 2025

Status Verified

September 1, 2024

Enrollment Period

7.2 years

First QC Date

June 22, 2022

Last Update Submit

June 26, 2025

Conditions

Prostate Cancer

Keywords

prostate cancerolder patientsimmediate curative treatmentconservative treatment

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    overall survival

    10 years following end of recruitment

  • 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)

    0-10 years

Secondary Outcomes (9)

  • Role functioning

    0-10 years

  • Urinary irritative/ obstructive symptoms

    0-10 years

  • bowel symptoms

    0-10 years

  • Prostate cancer morbidity

    0-10 years

  • Prostate-cancer-specific survival

    0-10 years

  • +4 more secondary outcomes

Other Outcomes (6)

  • Institutionalized care

    0-10 years

  • Health-related quality of life in cancer patients

    0-10 years

  • Health-related quality of life in older cancer patients

    0-10 years

  • +3 more other outcomes

Study Arms (2)

immediate curative therapy

EXPERIMENTAL

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.

Radiation: Radiotherapy or surgery

initial observation/ hormone therapy

ACTIVE COMPARATOR

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.

Other: initial observationDrug: Hormone therapy

Interventions

Radiotherapy or surgeryRADIATION

see arm/ group description

immediate curative therapy
initial observationOTHER

see arm/ group description

initial observation/ hormone therapy
Hormone therapyDRUG

androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy

initial observation/ hormone therapy

Eligibility Criteria

Age75 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males have prostate cancer
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Rigshospital

Copenhagen, Denmark

RECRUITING

Esbjerg and Grindsted Hospital

Esbjerg, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Helsinki University Hospital

Helsinki, 00029, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, 20520, Finland

RECRUITING

Sunmøre Hospital Trust

Ålesund, Møre og Romsdal, Norway

RECRUITING

Oslo University Hospital

Oslo, Oslo County, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Rogaland, Norway

RECRUITING

Sørlandet Hospital Trust

Kristiansand, Sørlandet, 4604, Norway

RECRUITING

Telemark Hospital Trust

Skien, Telemark, 3710, Norway

RECRUITING

St. Olavs Hospital

Trondheim, Trøndelag, 7006, Norway

RECRUITING

Vestfold Hospital Trust (Hospital of Vestfold)

Tønsberg, Vestfold, 3103, Norway

RECRUITING

Vestre Viken Hospital Trust

Drammen, 3004, Norway

RECRUITING

Innlandet Hospital Trust

Hamar, Norway

RECRUITING

Akerhus University Hospital

Lørenskog, 1478, Norway

RECRUITING

University Hospital of Northern Norway

Tromsø, Norway

RECRUITING

Capio Saint Göran's Hospital

Stockholm, 11219, Sweden

RECRUITING

Related Publications (1)

  • Loffeler S, Bertilsson H, Muller C, Aas K, Haugnes HS, Aksnessaether B, Pesonen M, Thon K, Tandstad T, Murtola T, Poulsen MH, Nordstrom T, Vigmostad MN, Ottosson F, Holmsten K, Christiansen O, Slaaen M, Haug ES, Storas AH, Asphaug L, Rannikko A, Brasso K; Scandinavian Prostate Cancer Group (SPCG) and the Norwegian Get-Randomized (GRand) Initiative. Protocol of a randomised, controlled trial comparing immediate curative therapy with conservative treatment in men aged >/=75 years with non-metastatic high-risk prostate cancer (SPCG 19/GRand-P). BJU Int. 2024 Jun;133(6):680-689. doi: 10.1111/bju.16314. Epub 2024 Mar 12.

    PMID: 38469686DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

RadiotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Sven Loffeler, MD, PhD

    The Hospital of Vestfold

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Loffeler, MD, PhD

CONTACT

+4792235628sven.loffeler@siv.no

Erik S Haug, MD, PhD

CONTACT

+4793030298erik.haug@siv.no

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, parallel, open-label
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 7, 2022

Study Start

November 4, 2022

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2036

Last Updated

July 1, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Only anonymized data will be shared

Locations

DK(3)SE(1)FI(3)NO(11)