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

NCT04794777 | Recruiting Phase 3

• 1 other identifier: PSMA recidiv
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 5

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

Keywords

PSMA PET/CT

Outcome Measures

Primary Outcomes (1)

• Primary PSA progression free survival

  Number of patients with progress defined by Prostate-Specific Antigen (PSA) measurement

  Throughout the study, approximately 10 years.

Secondary Outcomes (4)

• Time to metastasis

  At 5, 7 and 10 years

• Prostate cancer specific survival

  At 5, 7 and 10 years

• Time to secondary treatment

  At 5, 7 and 10 years

• Differences in quality of life recorded using Patient Reported Outcome Measure (PROM)

  Baseline, 6, 12, 36 and 60 months after completed treatment.

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Combination Product: Individualised therapy

Control arm

ACTIVE COMPARATOR

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

Radiation: Standard salvage therapy

Interventions

Individualised therapy 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.

Experimental arm

Standard salvage therapy RADIATION

Standard salvage radiotherapy

Control arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefan Carlsson: lead

Study Sites (5)

Sahlgrenska University Hospital

Gothenburg, Göteborg, 413 45, Sweden

RECRUITING

Södersjukhuset

Stockholm, Stockholm County, 118 83, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

RECRUITING

Norrland's University Hospital

Umeå, 901 85, Sweden

NOT YET RECRUITING

Örebro University Hospital

Örebro, Örebro County, 701 85, Sweden

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

Study Officials

• Stefan Carlsson

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Carlsson

CONTACT

0704871106; stefan.carlsson@ki.se

Yvonne Larsen

CONTACT

yvonne.larsen@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: October 30, 2018
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)