AzTrials
AzTrials

Prostate CancerPhase 3GrandP/SPCG19NCT05448547

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

A Phase 3 study testing Radiotherapy or surgery, initial observation and Hormone therapy in people with Prostate Cancer, run by Sven Löffeler at 26 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 75 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Radiotherapy or surgery, initial observation and Hormone therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
980 participants
Where
26 sitesin 4 countries
Study dates
4 Nov 2022to 31 Dec 2036
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • Men only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • Other Exclusions
  • Disabled or severe comorbidity (identified by G8 screening)
  • Unable to read, understand or fill out HRQoL questionnaires (PROMS)

Trial locations and contacts

26 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Sven Loffeler, MD, PhD contact

+4792235628

sven.loffeler@siv.no

Erik S Haug, MD, PhD contact

+4793030298

erik.haug@siv.no

26 sites in 4 countries

Norway11 sites, 11 recruiting

  • Sunmøre Hospital Trust

    Ålesund, Møre og Romsdal

    Bjørg Aksnessæther, +47 70105000, bjorg.y.aksnessether@helse-mr.no

    Recruiting

  • Vestre Viken Hospital Trust

    Drammen, 3004

    Jon G Tyrdal, MD, +47 32803000, jongt@hotmail.com

    Recruiting

  • Innlandet Hospital Trust

    Hamar

    Ola Christiansen, MD, +47 915 06 200, ola.christiansen@sykehuset-innlandet.no

    Recruiting

  • Sørlandet Hospital Trust

    Kristiansand, Sørlandet, 4604

    Christoph Müller, MD, PhD, +47 90610600, christoph.muller@sshf.no

    Recruiting

  • Akerhus University Hospital

    Lørenskog, 1478

    Kirsti Aas, MD, PhD, +47 55 97 50 00, kirstiaas@hotmail.com

    Recruiting

  • Oslo University Hospital

    Oslo

    Kristian Thon, MD, PhD, +47 98227869, uxktho@ous-hf.no

    Anne Marie Holck Storås, MD, PhD, +47 93208884, ANNHOL@ous-hf.no

    Recruiting

  • Telemark Hospital Trust

    Skien, Telemark, 3710

    Rasmus Nilsson, MD, +47 35003500, Rasmus.Nilsson@sthf.no

    Recruiting

  • Stavanger University Hospital

    Stavanger, Rogaland

    Maria Nyre Vigmostad, MD, +47 51518000, marianyr@gmail.com

    Recruiting

  • Vestfold Hospital Trust (Hospital of Vestfold)

    Tønsberg, Vestfold, 3103

    Sven Löffeler, +4733342000 ext. +4733342000, sven.loffeler@siv.no

    Erik S Haug, +4733342000 ext. +4733342000, erik.haug@siv.no

    Recruiting

  • University Hospital of Northern Norway

    Tromsø

    Hege S Haugnes, Prof, PhD, +47 776 26000, hege.sagstuen.haugnes@unn.no

    Recruiting

  • St. Olavs Hospital

    Trondheim, Trøndelag, 7006

    Torgrim M Tandstad, MD, PhD, Professor, +47 72573000, Torgrim.Tandstad@stolav.no

    Recruiting

Other trials in Norway

Sweden9 sites, 9 recruiting

  • Falu Lasarett

    Falun

    Nils Edström, MD, +460702742286, nils.edstrom@regiondalarna.se

    Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

    Katarina Koss Modig, MD, PhD, FEBU, +46730123-0640, katarina.koss.modig@vgregion.se

    Recruiting

  • Helsingborg/Ängelholm hospital

    Helsingborg

    Christian Torbrand, MD, PhD, Assosiate Professor, +46 76 8918588, christian.torbrand@skane.se

    Recruiting

  • Örebro University Hospital

    Örebro

    Henrik Ugge, MD, +46733391196, henrik.ugge@regionorebrolan.se

    Recruiting

  • Östersunds Hospital

    Östersund

    Andreas Lundgren, MD, +460735-33 68 55, andreas.m.lundgren@gmail.com

    Recruiting

  • Capio Saint Göran's Hospital

    Stockholm, 11219

    Karin Holmsten, MD, PhD, +46 8 587 010 00, karin.holmsten@capiostgoran.se

    Recruiting

  • Södersjukhuset

    Stockholm, 11883

    David Kurén, MD, david.kudren@regionstockholm.se

    Recruiting

  • Norrlands universitetssjukhus

    Umeå, 907 37

    Hani Adamo, MD, +460704717954, hani.adamo@regionvasterbotten.se

    Recruiting

  • Akademiska sjukhuset, Uppsala

    Uppsala

    Mats Ahlberg, MD, +46070-2072911, mats.ahlberg@uu.se

    Recruiting

Other trials in Sweden

Denmark3 sites, 3 recruiting

  • Rigshospital

    Copenhagen

    Klaus Brasso, Prof, PhD, +45 35 45 35 45, klaus.brasso@regionh.dk

    Recruiting

  • Esbjerg and Grindsted Hospital

    Esbjerg

    Mads Hvid Aaberg Poulsen, Associate Professor, +45 2176 5418, mads.poulsen@rsyd.dk

    Recruiting

  • Odense University Hospital

    Odense

    Grzegorz Lukasz H Fojecki, MD, PhD, +45 63 20 20 00, grzegorz.lukasz.fojecki@rsyd.dk

    Recruiting

Other trials in Denmark

Finland3 sites, 3 recruiting

  • Helsinki University Hospital

    Helsinki, 00029

    Antti Rannikko, Professor, MD, PhD, +358 9 4711

    Recruiting

  • Tampere University Hospital

    Tampere

    Teemu Murtola, Prof, PhD, +358 3 311 611, teemu.murtola@tuni.fi

    Recruiting

  • Turku University Hospital

    Turku, 20520

    Otto Ettala, MD, PhD, +358 2 313 0000, Otto.Ettala@tyks.fi

    Recruiting

Other trials in Finland

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Radiotherapy or surgery, initial observation, Hormone therapy
Keywords
prostate cancer, older patients, immediate curative treatment, conservative treatment
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy or surgeryRadiation

    see arm/ group description

  • initial observationOther

    see arm/ group description

  • Hormone therapyDrug

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

Study groups in NCT05448547
Study groupRoleWhat they receive
immediate curative therapyExperimentalPatients 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.
Receives: Radiation: Radiotherapy or surgery
initial observation/ hormone therapyActive comparatorPatients 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.
Receives: Other: initial observation; Drug: Hormone therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    overall survival

    Measured: 10 years following end of recruitment

  2. 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)

    Measured: 0-10 years

Secondary outcomes (9)

  1. 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)

    Measured: 0-10 years

  2. Urinary irritative/ obstructive symptoms

    Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26),urinary scales (score 0-100, higher scores indicating better outcomes)

    Measured: 0-10 years

  3. bowel symptoms

    Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), bowel scales (score 0-100, higher scores indicating better outcomes)

    Measured: 0-10 years

  4. Prostate cancer morbidity

    hospitalizations, interventions, complications due to local progression/ systemic progression)

    Measured: 0-10 years

  5. Prostate-cancer-specific survival

    Prostate cancer deaths in intervention and control group

    Measured: 0-10 years

  6. Metastasis-free survival

    time to metastasis detected radiographically due to symptoms or biochemical progression

    Measured: 0-10 years

  7. Symptom-/ intervention-free survival

    time to symptoms/ need for interventions due to prostate cancer progression

    Measured: 0-10 years

  8. Quality of life-adjusted years

    Euro QoL group questionaire (EQ-5D-5L) (1 =full health; 0= dead)

    Measured: 0-10 years

  9. need for secondary and tertiary therapy

    use of second- and third-line therapies

    Measured: 0-10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start4 Nov 2022
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, parallel, open-label
Masking
None (open label)
Enrolment
980 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05448547
Sponsor's protocol ID
GrandP
Acronym
GrandP/SPCG19
Status last verified
Sep 2026
First submitted
22 Jun 2022
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only anonymized data will be shared

Publications

  • 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.

    PubMed 38469686

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiotherapy or surgery, initial observation and Hormone therapy in people with Prostate Cancer, run by Sven Löffeler at 26 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Norway, Sweden, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sven Loffeler, MD, PhD (+4792235628, sven.loffeler@siv.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 10 years following end of recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05448547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
GrandP/SPCG19 Clinical Trial NCT05448547 | AzTrials