Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer

NCT ID: NCT04794777

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2027-10-30

Brief Summary

Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT.

Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact.

In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

Individualised therapy based on results of the PSMA PET/CT.

Group Type: EXPERIMENTAL

Individualised therapy

Intervention Type: COMBINATION_PRODUCT

Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed.

Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND).

Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND.

Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention.

Control arm

Standard salvage therapy. Results of PSMA PET/CT blinded.

Group Type: ACTIVE_COMPARATOR

Standard salvage therapy

Intervention Type: RADIATION

Standard salvage radiotherapy

Interventions

Individualised therapy

Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed.

Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND).

Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND.

Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention.

Intervention Type: COMBINATION_PRODUCT

Standard salvage therapy

Standard salvage radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA >0.2 <2.0 ng/mL, and increasing measured twice.
• Multidisciplinary conference (MDK) decision to offer the patient SRT
• Signed Informed Consent

Exclusion Criteria

• Patients previously treated for prostate cancer with biochemical recurrence
• Previous treatment with androgen deprivation therapy (ADT) after surgery
• Previous pelvic radiotherapy
• Patients with positive lymph nodes at surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Stefan Carlsson

OTHER

Sponsor Role: lead

Responsible Party

Stefan Carlsson

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stefan Carlsson

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Sahlgrenska University Hospital

Gothenburg, Göteborg, Sweden

Site Status: RECRUITING

Södersjukhuset

Stockholm, Stockholm County, Sweden

Site Status: NOT_YET_RECRUITING

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Site Status: RECRUITING

Norrland's University Hospital

Umeå, , Sweden

Site Status: NOT_YET_RECRUITING

Örebro University Hospital

Örebro, Örebro County, Sweden

Site Status: NOT_YET_RECRUITING

Countries

Sweden

Central Contacts

Stefan Carlsson

Role: CONTACT

stefan.carlsson@ki.se

0704871106 ext. 46

Yvonne Larsen

Role: CONTACT

yvonne.larsen@regionstockholm.se

Facility Contacts

Ola Bratt

Role: primary

ola.bratt@vgregion.se

Jon Kindblom

Role: backup

jon.kindblom@vgregion.se

Chunde Li

Role: primary

Chunde.Li@ki.se

Gunilla Sellerstam

Role: backup

gunilla.sellerstam@sll.se

Stefan Carlsson

Role: primary

stefan.carlsson@ki.se

Katarina Hammarlund

Role: backup

katarina.hammarlund@sll.se

Karin Söderkvist, MD

Role: primary

karin.soderkvist@umu.se

Camilla Thellenberg

Role: backup

camilla.thellenberg@umu.se

Janusz Frey, MD PhD

Role: primary

janusz.frey@regionorebrolan.se

Anna Messing-Eriksson

Role: backup

anna.messing-eriksson@regionorebrolan.se

Other Identifiers

PSMA recidiv

Identifier Type: -

Identifier Source: org_study_id