Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions

NCT07343349 | Recruiting DMC

• 1 other identifier: H-25028267
• Study Type: interventional
• Target: 1,016
• Locations: 1 country
• Sites: 3

Brief Summary

Every year, about 700 Danish men get radiotherapy for prostate cancer with a high-risk of later progression. The risk of relapse is about 40 % after 5 - 8 years, so we need better treatment for these patients in Denmark and globally. The aim is to reduce later cancer spreading, need of hormone treatments and prostate cancer death. DAPROCA 10 tests two possible improvements: If a higher dose (boost) to intra-prostatic tumor lesions improves cure rates. If the radiotherapy can be given with 12 treatment fractions instead of 20 without increased side-effects. In this randomised trial half the participants get a boost and the other half don't. Half the patients get 12 treatments, the other half 20. To answer these questions we must include1016 participants. The trial is feasible because the technological advances in imaging and radiotherapy enables us to define the tumors in the prostate and to deliver the boost to the tumors with high precision, without increased dose to the surrounding organs.

Conditions

Prostate Cancer Patients Undergoing External Radiation and Seed Implantation; High Risk Localised Prostate Carcinoma; Locally Advanced Prostate Cancer; Unfavourable Intermediate Risk Prostate Cancer

Keywords

Prostate cancer; Radiotherapy; Hypofractionation; Boost

Outcome Measures

Primary Outcomes (1)

• Freedom from distant metastasis

  Metastses is verified by PSMA scan which is recommended: * If a recurrence is suspected biochemically according to biochemical relaps accordingly to the Phoenix criteria * If a recurrence is suspected clinically, e.g: Bone pain, anemia, urinary symptoms * If recurrence is suspected by radiographic test Biopsy is also accepted and MRI, CT, bone scintigraphy, NAF-PET, ultrasound or clinical examination may also be accepted with further confirmation, e.g. biopsy or laboratory tests. If the event "distant metastasis" is based on tests without biopsy or PSMA positivity the event shall be confirmed at a multi-disciplinary tumor board.

  Time from enrollment to confirmation of occurence of radigraphic distant metastases. The patients are followed for 123 months after start of radiotherapy.

Secondary Outcomes (9)

• Freedom from biochemical relapse

  Time from enrollment to confirmation of occurence of biochemical relapse. PSA is measured by a blood test regularly until 123 months after start of radiotherapy.

• Time to salvage hormonal therapy

  Time from enrollment to intiation of salvage hormonal therapy. Hormone treatment is recordet at regular patient visits until 123 months after start of radiotherapy.

• Regional relapse-free survival

  Time from enrollment to confirmation of regional relapse-free survival. Time Frame: The patients are followed for 123 months after start of radiotherapy.

• Local relapse-free survival

  Time from enrollment to confirmation of local relapse. The participants are followed for 123 months after start of radiotherapy

• Overall survival

  Time from enrollment to death of any cause. Cause and time of death is collected for up to 20 years.

Study Arms (4)

20 treatment fractions no boost

ACTIVE COMPARATOR

Prostate and seminal vesicles: 60 Gy/ 20 fractions. Pelvic: 45 Gy /20 fractions.

Radiation: Addition of focal boost and hypofractionation

20 treatment fractions, boost

EXPERIMENTAL

Boost to intra-prostatic lesions: 75 Gy/20 fractions, prostate and seminal vesicles: 60 Gy/ 20 fractions. Pelvic: 45 Gy /20 fractions.

Radiation: Addition of focal boost and hypofractionation

12 treatment fractions, no boost

EXPERIMENTAL

Prostate and seminal vesicles: 50 Gy/ 12 fractions, Pelvic: 37 Gy /12 fractions.

Radiation: Addition of focal boost and hypofractionation

12 fractions, boost

EXPERIMENTAL

Boost to intraprostatic lesions: 60 Gy/12 fractions, prostate and seminal vesicles: 50 Gy/12 fractions, pelvic: 37 Gy /12 fractions.

Radiation: Addition of focal boost and hypofractionation

Interventions

Addition of focal boost and hypofractionation RADIATION

Addition of focal boost to primary radiotherapy for prostate cancer in 12 or 20 fractions

12 fractions, boost; 12 treatment fractions, no boost; 20 treatment fractions no boost; 20 treatment fractions, boost

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biopsy verified PCa with no distant metastases with either
• Intermediate- or high-risk PCa, defined as at least one of the following risk criteria:
• Clinical stage cT2c-T3b (UICC TNM 8th edition)
• Imaging stage, T3a or T3b
• ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
• Regional lymph node metastases N1
• Age \> 18
• WHO score 0-1
• Intraprostatic lesion visible on MRI
• Suitable for focal boost
• Ability to give written informed consent and willingness to return for follow-up

You may not qualify if:

• WHO performance status ≥ 2
• If, for any patient related reason, an MRI cannot be performed
• International prostate symptom score (IPSS) ≧ 20
• If fiducial markers cannot be inserted
• TURP within 3 months from start of treatment
• Previous pelvic irradiation
• If the patient is judged by the physician to be unable to adhere to trial activities
• History of chronic inflammatory bowel disease (CIBD)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Sygehus Lillebaelt: collaborator
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Naestved Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (3)

Aurhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Sygehus Lillebaelt

Vejle, 7000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Peter Meidahl Petersen,, MD., PhD.

CONTACT

+45 35450603; peter.meidahl.petersen@regionh.dk

Peter M Petersern, MD., PhD.

CONTACT

+45 35450603; peter.meidahl.petersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.

Model Details: The trial is an open, randomised, 2 x 2 factorial design, randomising between: 1. Boost or no boost to intra-prostatic tumour lesions. 2. 20 fractions in 4 weeks versus 12 fractions in 2½ weeks.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 15, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 30, 2040
• Study Completion (Estimated): October 30, 2040
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Not decided yet.
• Access Criteria: Not decided yet.

Locations

DK (3)