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NCT Number: NCT04794777

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Sahlgrenska University Hospital, Gothenburg, Göteborg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard salvage therapy

Radiation

Standard salvage radiotherapy

Primary outcomes

  1. Primary PSA progression free survival

    Time frame: Throughout the study, approximately 10 years.

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

Secondary outcomes

  1. Time to metastasis

    Time frame: At 5, 7 and 10 years

    Time to documented metastasis of prostate cancer

  2. Prostate cancer specific survival

    Time frame: At 5, 7 and 10 years

    Time to prostate cancer specific death

  3. Time to secondary treatment

    Time frame: At 5, 7 and 10 years

    Time to need for secondary treatment for prostate cancer

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

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

    A modified version of the PSMA questionnaire developed by the National Prostate Cancer Register. Scale from 1 to 5 were 1 is very good and 5 is very bad.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Carlsson

CONTACT

[email protected]

0704871106 ext. 46

Yvonne Larsen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stefan Carlsson

Other

Registry information

Official study title

A Randomized Trial Comparing Conventional "Salvage" Radiotherapy and Individualized 68Ga-PSMA-11 or 18F-PSMA-1007 PET/CT Targeted Treatment in Patients With Biochemical Recurrence After Prostate Cancer Surgery

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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